Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2015-003034-27 | EudraCT Number |
Not provided
Not provided
This study was discontinued due to an interim analysis in this study, which indicated that Crenezumab was unlikely to meet its primary endpoint.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This randomized, double-blind, placebo-controlled, parallel group study will evaluate the efficacy and safety of crenezumab versus placebo in participants with prodromal to mild AD. Participants will be randomized 1:1 to receive either intravenous (IV) infusion of crenezumab or placebo every 4 weeks (Q4W) for 100 weeks. The final efficacy and safety assessment will be performed 52 weeks after the last crenezumab dose. Participants will then have the option to enter the Open Label Extension (OLE) study if eligible. Participants who do not enter the OLE study will have additional follow-up visits at 16 and 52 weeks after the last dose, primarily for safety and also for limited efficacy assessments.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Participants received intravenous (IV) infusion of Placebo every 4 weeks (Q4W) for 100 weeks. |
|
| Crenezumab | Experimental | Participants received intravenous (IV) infusion of Crenezumab every 4 weeks (Q4W) for 100 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Crenezumab | Drug | Crenezumab was administered by intravenous (IV) infusion at 60mg/kg as per the dosing schedule described above. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline to Week 105 in Clinical Dementia Rating-Sum of Boxes (CDR-SB) Score | The CDR-SB rates impairment in 6 categories (memory, orientation, judgement and problem solving, community affairs, home and hobbies and personal care) on a 5-point scale in which no impairment = 0, questionable impairment = 0.5 and mild, moderate and severe impairment = 1, 2 and 3 respectively. The score range is from 0 to 18 with a high score indicating a high disease severity. The difference in mean change from Baseline to Week 105 between Crenezumab and Placebo treated participants was estimated. Mixed model repeated measures (MMRMs) adjusting for disease severity, APOEe4 status, geographic region and the use or non-use of anti-dementia medications at baseline were used to estimate the mean change from baseline for this primary endpoint. Data after 29 January 2019 are censored for the primary and secondary efficacy analyses to avoid potential biases due to investigators, participants, raters, etc. being potentially influenced by early closure of the study due to lack of efficacy. | Baseline, Week 105 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline to Week 105 on Cognition, as Assessed by Alzheimer's Disease Assessment Scale-Cognition (ADAS-Cog) (Subscale) 13 (ADAS-Cog-13) | The ADAS-Cog-13 assesses multiple cognitive domains including memory, comprehension, praxis, orientation, and spontaneous speech. Most of these are assessed by tests although some are rated by the clinician on a 5-point scale. The ADAS-Cog-13 is the ADAS-Cog-11 with 2 further items: delayed word recall and total digit cancellation. The score range for ADAS-Cog-13 is from 0 to 85 with high scores representing severe dysfunction. The difference in mean change from Baseline to Week 105 between Crenezumab and Placebo treated participants was estimated. Mixed model repeated measures (MMRMs) adjusting for disease severity, APOEe4 status, geographic region, and the use or non-use of anti-dementia medications at baseline were used to estimate the mean change from baseline. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
If considered to be cured or If not being actively treated with anti-cancer therapy or radiotherapy
- Known history of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric, human, or humanized antibodies or fusion proteins
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Banner Alzheimer's Institute | Phoenix | Arizona | 85006 | United States | ||
| Pharmacology Research Inst |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41537338 | Derived | Hibar DP, Bauer A, Rabe C, Borlinghaus N, Jethwa A, Kollmorgen G, Di Domenico A, Zetterberg H, Blennow K, Masters CL, Sperling RA, Bittner T. Elecsys pTau217 plasma immunoassay detection of amyloid pathology in clinical cohorts. Alzheimers Dement. 2026 Jan;22(1):e71009. doi: 10.1002/alz.71009. | |
| 40603145 | Derived |
Not provided
Not provided
A total of 813 participants were enrolled at 249 centers. 4 participants did not receive any study treatment meaning that the modified intent-to-treat and safety populations both consisted of 809 participants.
The study was conducted at 249 centers in 30 countries.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Participants received intravenous (IV) infusion of Placebo every 4 weeks (Q4W) for 100 weeks. |
| FG001 | Crenezumab | Participants received intravenous (IV) infusion of Crenezumab every 4 weeks (Q4W) for 100 weeks. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 10, 2018 |
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo | Drug | Placebo was administered by intravenous (IV) infusion at 60mg/kg as per the dosing schedule described above. |
|
| Baseline, Week 105 |
| Change From Baseline to Week 105 on Cognition, as Assessed by Alzheimer's Disease Assessment Scale-Cognition (ADAS-Cog) (Subscale) 11 (ADAS-Cog-11) | The ADAS-Cog-11 assesses multiple cognitive domains including memory, comprehension, praxis, orientation, and spontaneous speech. Most of these are assessed by tests although some are rated by the clinician on a 5-point scale. The score range for ADAS-Cog-11 is from 0 to 70 with high scores representing severe dysfunction. The difference in mean change from Baseline to Week 105 between Crenezumab and Placebo treated participants was estimated. Mixed model repeated measures (MMRMs) adjusting for disease severity, APOEe4 status, geographic region, and the use or non-use of anti-dementia medications at baseline were used to estimate the mean change from baseline. | Baseline, Week 105 |
| Change From Baseline to Week 105 on Severity of Dementia, Assessed Using the CDR-Global Score (CDR-GS) | The CDR-GS represents a semi-structured interview which rates impairment in 6 categories (memory, orientation, judgement and problem solving, community affairs, home and hobbies, and personal care) on a 5-point scale in which CDR 0 = no dementia and CDR 0.5, 1, 2 or 3 = questionable, mild, moderate or severe dementia respectively. The range in scores for the CDR-GS is from 0 to 3 and a high score on the CDR-GS would indicate a high disease severity. The difference in mean change from Baseline to Week 105 between Crenezumab and Placebo treated participants was estimated. Mixed model repeated measures (MMRMs) adjusting for disease severity, APOEe4 status, geographic region, and the use or non-use of anti-dementia medications at baseline were used to estimate the mean change from baseline. | Baseline, Week 105 |
| Change From Baseline to Week 105 on Severity of Dementia, Assessed Using the Mini Mental State Evaluation (MMSE) | The MMSE is a set of standardized questions used to evaluate possible cognitive impairment and help stage the severity level of this impairment. The questions target 6 areas: orientation, registration, attention, short-term recall, language and constructional praxis/visuospatial abilities. The scores on the MMSE range from 0 to 30, with higher scores indicating better function. The difference in mean change from Baseline to Week 105 between Crenezumab and Placebo treated participants was estimated. Mixed model repeated measures (MMRMs) adjusting for disease severity, APOEe4 status, geographic region, and the use or non-use of anti-dementia medications at baseline were used to estimate the mean change from baseline. | Baseline, Week 105 |
| Change From Baseline to Week 105 on Function as Assessed by the ADCS-ADL Total Score | The ADCS-ADL (Alzheimer's Disease Cooperative Study-Activities of Daily Living) is the scale most widely used to assess functional outcomes in participants with AD. The ADCS-ADL covers both basic ADL (e.g., eating and toileting) and more complex 'instrumental' ADL or iADL (e.g., using the telephone, managing finances and preparing a meal). The ADCS-ADL consists of 23 questions with a score range of 0 to 78 where a higher score represents better function. The difference in mean change from Baseline to Week 105 between Crenezumab and Placebo treated participants was estimated. Mixed model repeated measures (MMRMs) adjusting for disease severity, APOEe4 status, geographic region, and the use or non-use of anti-dementia medications at baseline were used to estimate the mean change from baseline. | Baseline, Week 105 |
| Change From Baseline to Week 105 on Function as Assessed by the ADCS-instrumental (ADCS-iADL) Subscore | The ADCS-iADL (Alzheimer's Disease Cooperative Study-Instrumental Activities of Daily Living) measures activities such as using the telephone, managing finances and preparing a meal. The ADCS-iADL consists of 16 questions with a score range of 0 to 56 where a higher score represents better function. The difference in mean change from Baseline to Week 105 between Crenezumab and Placebo treated participants was estimated. Mixed model repeated measures (MMRMs) adjusting for disease severity, APOEe4 status, geographic region, and the use or non-use of anti-dementia medications at baseline were used to estimate the mean change from baseline. | Baseline, Week 105 |
| Change From Baseline to Week 105 on a Measure of Dependence Derived From the ADCS-ADL Score | The ADCS-ADL (Alzheimer's Disease Cooperative Study-Activities of Daily Living) is the scale most widely used to assess functional outcomes in participants with AD. The ADCS-ADL covers both basic ADL (e.g., eating and toileting) and more complex 'instrumental' ADL or iADL (e.g., using the telephone, managing finances and preparing a meal). The ADCS-ADL consists of 23 questions with a score range of 0 to 78 where a higher score represents better function. The difference in mean change from Baseline to Week 105 between Crenezumab and Placebo treated participants was estimated. Mixed model repeated measures (MMRMs) adjusting for disease severity, APOEe4 status, geographic region, and the use or non-use of anti-dementia medications at baseline were used to estimate the mean change from baseline. | Baseline, Week 105 |
| Change From Baseline to Week 105 Assessed Using the Neuropsychiatric Inventory Questionnaire (NPI-Q) | The NPI-Q is an informant-based instrument that evaluates 12 neuropsychiatric disturbances common in dementia: delusions, hallucinations, agitation, dysphoria, anxiety, apathy, irritability, euphoria, disinhibition, aberrant motor behavior, night-time behavioral disturbances and appetite and eating abnormalities. The severity of each neuropsychiatric symptom is rated on a 3-point scale (mild, moderate and marked). The total severity score range is from 0 to 36 with higher scores representing higher severity. The difference in mean change from Baseline to Week 105 between Crenezumab and Placebo treated participants was estimated. Mixed model repeated measures (MMRMs) adjusting for disease severity, APOEe4 status, geographic region, and the use or non-use of anti-dementia medications at baseline were used to estimate the mean change from baseline. | Baseline, Week 105 |
| Quality of Life-Alzheimer's Disease (QoL-AD) Scale Score | The QoL-AD (Quality of Life - Alzheimer's Disease) scale assesses QoL in participants who have dementia. The QoL-AD consists of 13 items covering aspects of participants' relationships with friends and family, physical condition, mood, concerns about finances and overall assessment of QoL. Items are rated on 4-point Likert-type scales ranging from 1 [poor] to 4 [excellent]. The score range is from 13 to 52, with higher scores indicating a better QoL. The difference in mean change from Baseline to Week 105 between Crenezumab and Placebo treated participants was estimated. Mixed model repeated measures (MMRMs) adjusting for disease severity, APOEe4 status, geographic region, and the use or non-use of anti-dementia medications at baseline were used to estimate the mean change from baseline. | Baseline up to Week 105 |
| Zarit Caregiver Interview for Alzheimer's Disease (ZCI-AD) Scale Score | The ZCI-AD is a modified version of the Zarit Burden Interview, which was originally designed to reflect the stresses experienced by caregivers of people with dementia. This modified version includes slight modifications in item and title wording (e.g., removal of "your relative" to refer directly to the patient, removal of "burden" from title) and the use of 11-point numerical rating scales. The ZCI-AD scale consists of a total of 30 items. Total scores will be calculated with a total score range from 0 to 300 (higher scores indicate a higher burden on the caregiver). The difference in mean change from Baseline to Week 105 between Crenezumab and Placebo treated participants was estimated. Mixed model repeated measures (MMRMs) adjusting for disease severity, APOEe4 status, geographic region, and the use or non-use of anti-dementia medications at baseline were used to estimate the mean change from baseline. | Baseline up to Week 105 |
| EQ-5D Questionnaire Domain Score for Participants | The EQ-5D is a standardized measure of health status designed to provide a simple generic measure of health for clinical and economic appraisal. It is broadly applicable across a wide range of health conditions and treatment. The EQ-5D assesses five domains to provide a health state index. These are anxiety/depression, pain/discomfort, usual activities, mobility, and self-care. The scores on the EQ-5D ranges from 0 (worst imaginable health state) to 100 (best imaginable health state). The difference in mean change from Baseline to Week 105 between Crenezumab and Placebo treated participants was estimated. Mixed model repeated measures (MMRMs) adjusting for disease severity, APOEe4 status, geographic region, and the use or non-use of anti-dementia medications at baseline were used to estimate the mean change from baseline. | Baseline up to Week 105 |
| EQ-5D Questionnaire Domain Score for Caregivers | The EQ-5D is a standardized measure of health status designed to provide a simple generic measure of health for clinical and economic appraisal. It is broadly applicable across a wide range of health conditions and treatment. The EQ-5D assesses five domains to provide a health state index. These are anxiety/depression, pain/discomfort, usual activities, mobility, and self-care. The scores on the EQ-5D ranges from 0 (worst imaginable health state) to 100 (best imaginable health state). The difference in mean change from Baseline to Week 105 between Crenezumab and Placebo treated participants was estimated. Mixed model repeated measures (MMRMs) adjusting for disease severity, APOEe4 status, geographic region, and the use or non-use of anti-dementia medications at baseline were used to estimate the mean change from baseline. | Baseline up to Week 105 |
| Percentage of Participants With Adverse Event (AEs) and Serious Adverse Event (SAEs) | An Adverse Event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events. | Baseline up until 16 weeks after the last dose of study drug (up to 117 weeks). |
| Percentage of Participants With Anti-Crenezumab Antibodies | Participants were considered positive or negative for ADA based on their baseline and post-baseline sample results. The number and percentage of participants with confirmed positive ADA levels were determined for Crenezumab and Placebo groups. The prevalence of ADA at baseline was calculated as the proportion of participants with confirmed positive ADA levels at baseline relative to the total number of participants with a sample available at baseline. The incidence of treatment-emergent ADAs was determined as the proportion of participants with confirmed post-baseline positive ADAs relative to the total number of participants that had at least one post-baseline sample available for ADA analysis. | Baseline up to Week 105 |
| Serum Concentration of Crenezumab | Serum concentration data for Crenezumab will be tabulated and summarized. Descriptive summary statistics will include the arithmetic mean and SD. Since a sparse PK sampling design is being used, population (non-linear mixed-effects) modeling will be used to analyze the dose concentration-time data of crenezumab. Information from other clinical studies may be incorporated to establish the PK model. Please note that Post-dose samples were not collected at Weeks 37 and 105. | Pre-infusion (0 hour), 60-90 minutes post-infusion on Day 1 Week 1 and on Week 25; Weeks 13, 37 (Pre-dose), 53, 77 and 105 (infusion length = as per the Pharmacy Manual) |
| Plasma Amyloid Beta (Abeta) 40 Concentrations | Plasma Abeta 40 concentrations will be measured over time and descriptive summary statistics will include the arithmetic mean and SD. Please note that a Post-dose sample was only collected at Week 13. | Week 1 Day 1; Weeks 13, 25, 53, 77 and 105 |
| Plasma Amyloid Beta (Abeta) 42 Concentrations | Plasma Abeta 42 concentrations will be measured over time and descriptive summary statistics will include the arithmetic mean and SD. Please note that a Post-dose sample was only collected at Week 13. | Week 1 Day 1; Weeks 13, 25, 53, 77 and 105 |
| Percentage Change From Baseline to Week 105 in Whole Brain Volume as Determined by Magnetic Resonance Imaging (MRI) | Percentage Change in Whole Brain Volume will be measured over time and descriptive summary statistics will include the arithmetic mean, median, range, SD, and coefficient of variation, as appropriate. Mixed model repeated measures (MMRMs) adjusting for disease severity, APOEe4 status, geographic region, and the use or non-use of anti-dementia medications at baseline were used to estimate the mean change from baseline. | Baseline, Week 105 |
| Percentage Change From Baseline to Week 105 in Ventricle Volume as Determined by Magnetic Resonance Imaging (MRI) | Percentage Change in Ventricle Volume will be measured over time and descriptive summary statistics will include the arithmetic mean, median, range, SD, and coefficient of variation, as appropriate. Mixed model repeated measures (MMRMs) adjusting for disease severity, APOEe4 status, geographic region, and the use or non-use of anti-dementia medications at baseline were used to estimate the mean change from baseline. | Baseline, Week 105 |
| Percentage Change From Baseline to Week 105 in Hippocampal Volume as Determined by Magnetic Resonance Imaging (MRI) | Percentage Change in Hippocampal Volume will be measured over time and descriptive summary statistics will include the arithmetic mean, median, range, SD, and coefficient of variation, as appropriate. Mixed model repeated measures (MMRMs) adjusting for disease severity, APOEe4 status, geographic region, and the use or non-use of anti-dementia medications at baseline were used to estimate the mean change from baseline. | Baseline, Week 105 |
| Encino |
| California |
| 91316 |
| United States |
| Collaborative Neuroscience Network Inc. | Long Beach | California | 90502 | United States |
| Alliance for Wellness, dba Alliance for Research | Long Beach | California | 90807 | United States |
| Pharmacology Research Institute | Los Alamitos | California | 90720 | United States |
| USC Keck School Of Medicine | Los Angeles | California | 90033 | United States |
| UCLA Medical Center, Department of Neurology | Los Angeles | California | 90095 | United States |
| Pharmacology Research Inst | Newport Beach | California | 92660 | United States |
| Shankle Clinic | Newport Beach | California | 92663 | United States |
| Stanford Univ Medical Center | Palo Alto | California | 94304 | United States |
| Anderson Clinical Research, Inc. | Redlands | California | 92374 | United States |
| University of California, Davis; Alzheimers Disease Center, Department of Neurology | Sacramento | California | 95817 | United States |
| UCSF - Memory and Aging Center | San Francisco | California | 94158 | United States |
| Neurological Research Inst | Santa Monica | California | 90404 | United States |
| North Bay Neuro Science Institute | Sebastopol | California | 95472 | United States |
| Associated Neurologists PC - Danbury | Danbury | Connecticut | 06810 | United States |
| Institute for Neurodegenerative Disorders | New Haven | Connecticut | 06510 | United States |
| Yale University School Of Medicine | New Haven | Connecticut | 06510 | United States |
| Research Center for Clinical Studies, Inc. | Norwalk | Connecticut | 06851 | United States |
| Bradenton Research Center | Bradenton | Florida | 34205 | United States |
| Quantum Laboratories | Deerfield Beach | Florida | 33064 | United States |
| Brain Matters Research, Inc. | Delray Beach | Florida | 33445 | United States |
| Galiz Research, LLC | Hialeah | Florida | 33016 | United States |
| Jacksonville Center For Clinical Research | Jacksonville | Florida | 32216 | United States |
| Alzheimer's Research and Treatment Center | Lake Worth | Florida | 33414 | United States |
| Merritt - Island Medical Research | Merritt Island | Florida | 32952 | United States |
| Miami Jewish Health Systems | Miami | Florida | 33137 | United States |
| Renstar Medical Research | Ocala | Florida | 34470 | United States |
| Bioclinica Research | Orlando | Florida | 32806 | United States |
| Progressive Medical Research | Port Orange | Florida | 32127 | United States |
| Johnnie B. Byrd Sr. Alzheimer's Center & Research Institute | Tampa | Florida | 33613 | United States |
| Stedman Clinical Trials, LLC | Tampa | Florida | 33613 | United States |
| Compass Research | The Villages | Florida | 32162 | United States |
| Emory University | Atlanta | Georgia | 30329 | United States |
| NeuroStudies.net, LLC | Decatur | Georgia | 30033 | United States |
| Alexian Brothers Neurosci Inst | Elk Grove Village | Illinois | 60007 | United States |
| Southern Illinois University, School of Medicine | Springfield | Illinois | 62702 | United States |
| Indiana University | Indianapolis | Indiana | 46202 | United States |
| MidAmerica Neuroscience Institute | Prairie Village | Kansas | 66206 | United States |
| Maine Research Associates | Auburn | Maine | 04210 | United States |
| MMP Neurology | Scarborough | Maine | 04074 | United States |
| Springfield Neurology Associates | Springfield | Massachusetts | 01104 | United States |
| Precise Research Centers | Flowood | Mississippi | 39232 | United States |
| The Cognitive and Research Center of New Jersey | Springfield | New Jersey | 07081 | United States |
| Advanced Memory Research Institute of NJ | Toms River | New Jersey | 08755 | United States |
| Albany Medical Faculty Physicians COmmunity Division. The Neurology Group | Albany | New York | 12206 | United States |
| Neurological Associates of Albany, PC | Albany | New York | 12208 | United States |
| Dent Neurological Institute | Amherst | New York | 14226 | United States |
| Columbia University Medical Center | New York | New York | 10032 | United States |
| South Shore Neurologic Associates P.C. | Patchogue | New York | 11772 | United States |
| Behavioral Health Research | Charlotte | North Carolina | 28211 | United States |
| Guilford Neurologic Associates | Greensboro | North Carolina | 27401 | United States |
| Valley Medical Primary Care | Centerville | Ohio | 45459 | United States |
| Insight Clinical Trials LLC | Shaker Heights | Ohio | 44122 | United States |
| Oklahoma Clinical Research | Oklahoma City | Oklahoma | 73112 | United States |
| Cutting Edge Research Group | Oklahoma City | Oklahoma | 73116 | United States |
| Central States Research | Tulsa | Oklahoma | 74136 | United States |
| Summit Research Network Inc. | Portland | Oregon | 97210 | United States |
| Drexel Univ College of Med; Clinical Research Group | Philadelphia | Pennsylvania | 19102 | United States |
| Abington Neurological Associates | Willow Grove | Pennsylvania | 19090 | United States |
| Senior Adults Specialty Research | Austin | Texas | 78757 | United States |
| Kerwin Research Center, LLC | Dallas | Texas | 75231 | United States |
| University of North Texas Health Science Center; Fort Worth Patient Care Center | Fort Worth | Texas | 76107 | United States |
| Sentara Medical Group | Norfolk | Virginia | 23507 | United States |
| National Clinical Research Inc.-Richmond | Richmond | Virginia | 23294 | United States |
| Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 | United States |
| The Queen Elizabeth Hospital; Neurology | Woodville | South Australia | 5011 | Australia |
| Caulfield Hospital; Aged Psychiatry Research Unit | Caulfield | Victoria | 3162 | Australia |
| Heidelberg Repatriation Hospital; Medical and Cognitive Research Centre | Heidelberg West | Victoria | 3081 | Australia |
| Neurodegenerative Disorders Research; Neurology | West Perth | Western Australia | 6005 | Australia |
| Konventhospital Barmherzige Brüder; Neurologie I | Linz | 4021 | Austria |
| UZ Gent | Ghent | 9000 | Belgium |
| ACIBADEM CITY CLINIC TOKUDA HOSPITAL EAD; Clinic of Neurology and Sleep Medicine | Sofia | 1407 | Bulgaria |
| Alexandrovska hospital; Neurology Department | Sofia | 1431 | Bulgaria |
| Vancouver Hospital - UBC Hospital Site | Vancouver | British Columbia | V6Z 1Y6 | Canada |
| Vancouver Island Health Authority | Victoria | British Columbia | V8R 1J8 | Canada |
| Parkwood Hospital; Geriatric Medicine | London | Ontario | N6C 5J1 | Canada |
| Bruyere Continuing Care | Ottawa | Ontario | K1N 5C8 | Canada |
| Kawartha Centre - Redefining Healthy Aging | Peterborough | Ontario | K9H 2P4 | Canada |
| The Centre for Memory and Aging | Toronto | Ontario | M4G 3E8 | Canada |
| Toronto Western Hospital | Toronto | Ontario | M5T 2S8 | Canada |
| Devonshire Clinical Research Inc. | Woodstock | Ontario | N4S 5P5 | Canada |
| CHA Hopital de I enfant-Jesus | Québec | Quebec | G1J 1Z4 | Canada |
| Hospital Clínica Biblica | San José | 10101 | Costa Rica |
| ICIMED Instituto de Investigación en Ciencias Médicas | San José | 10108 | Costa Rica |
| Clinical Hospital Centre Zagreb;Clinic for Neurology | Zagreb | 10000 | Croatia |
| Charles University, Medical faculty, Hradec Kralove ;Department of Neurology | Hradec Králové | 500 05 | Czechia |
| General Teaching Hospital, Departmetn of Neurology | Prague | 110 00 | Czechia |
| Aarhus Universitetshospital, Neurologisk Afdeling F, Demensklinikken | Aarhus N | 8200 | Denmark |
| Rigshospitalet, Hukommelsesklinikken | København Ø | 2100 | Denmark |
| Terveystalo Tampere | Tampere | 33100 | Finland |
| CRST Oy | Turku | 20520 | Finland |
| Hopital Avicenne; Neurologie | Bobigny | 93009 | France |
| Hopital neurologique Pierre Wertheimer - CHU Lyon; Neurologie | Bron | 69677 | France |
| Hopital Gui de Chauliac; Neurologie | Montpellier | 34295 | France |
| Hopital Lariboisiere | Paris | 75475 | France |
| CHU Poitiers - Hopital La Miletrie | Poitiers | 86000 | France |
| Hopital Hautepierre; Centre dInvestigation Clinique | Strasbourg | 67098 | France |
| CHU Toulouse - La Grave | Toulouse | 31059 | France |
| Neurologische Praxis Dr. Andrej Pauls | München | 80331 | Germany |
| Klinikum rechts der Isar der TU München; Klinik für Psychiatrie und Psychotherapie | München | 81675 | Germany |
| Universitätsklinikum Münster; Klinik und Poliklinik für Neurologie | Münster | 48149 | Germany |
| Steinwachs Klaus; Arztpraxis fur Neurologie u. Psychiatrie | Nuremberg | 90402 | Germany |
| Universitätsklinikum Rostock Zentrum für Nervenheilkunde | Rostock | 18147 | Germany |
| Universitätsklinikum Ulm; Klinik für Neurologie | Ulm | 89081 | Germany |
| Studienzentrum Nordwest, Dr. med. Joachim Springub / Herr Wolfgang Schwarz | Westerstede | 26655 | Germany |
| Forschungszentrum Ruhr | Witten | 58455 | Germany |
| Prince of Wales Hospital; Dept. of Medicine & Therapeutics | Hong Kong | Hong Kong |
| Queen Mary Hospital, Division of Geriatric Medicine | Hong Kong | Hong Kong |
| Semmelweis University; Department of Neurology | Budapest | 1083 | Hungary |
| Szabolcs-Szatmár-Bereg Megyei Kórházak - Jósa András Oktatókórház; Pszichiátria | Nyíregyháza | 4400 | Hungary |
| University of Szeged; Department of Psychiatry | Szeged | 6725 | Hungary |
| Szent Borbala Korhaz; Neurologiai es Stroke Osztaly | Tatabánya | 2800 | Hungary |
| Jávorszky Ödön Kórház, Neurológia és stroke osztály | Vác | 2600 | Hungary |
| Fondazione Santa Lucia IRCCS; Neurologia e Riabilitazione Neurologica | Rome | Lazio | 00179 | Italy |
| Ospedale San Giovanni Calibita Fatebenefratell;Neurologia | Rome | Lazio | 00186 | Italy |
| Ente Ospedaliero Ospedali Galliera; Ambulatorio di Neurologia | Genoa | Liguria | 16128 | Italy |
| Casa di Cura Policlinico; Dipartimento di Scienze Neuroriabilitative | Milan | Lombardy | 20144 | Italy |
| Ospedale S. Maria Nascente; Fondazione Don Gnocchi; Dip. Neurologia Riabilitativa | Milan | Lombardy | 20148 | Italy |
| Ospedale Casati Passirana di Rho; Centro Regionale Alzheimer | Passirana | Lombardy | 20017 | Italy |
| Azienda Ospedaliera Di Perugia Ospedale s. Maria Della Misericordia; S.C. Geriatria | Perugia | Umbria | 06129 | Italy |
| Miyoshi Clinic of Neurology, Hananosato | Hiroshima | 728-0013 | Japan |
| National Hospital Organization Hiroshima-Nishi Medical Center | Hiroshima | 739-0696 | Japan |
| Rakuwakai Otowarehabilitation Hospital | Kyoto | 607-8113 | Japan |
| Mie University Hospital | Mie | 514-8507 | Japan |
| National Hospital Organization Matsumoto Medical Center | Nagano | 399-8701 | Japan |
| Saigata Medical Center | Niigata | 949-3193 | Japan |
| Katayama Medical Clinic | Okayama | 710-0813 | Japan |
| Tokyo Medical University Hospital | Tokyo | 160-0023 | Japan |
| Tokyo Metropolitan Geriatric Hospital | Tokyo | 173-0015 | Japan |
| National Center of Neurology and Psychiatry | Tokyo | 187-8551 | Japan |
| Vilnius University Hospital Santariskiu Clinic | Vilnius | 08661 | Lithuania |
| Hospital Angeles de Culiacán, Neurociencias Estudios Clínicos SC | Culiacán | 80020 | Mexico |
| Hospital Uni; Dr. Jose E. Gonzalez | Monterrey | 64460 | Mexico |
| AVIX Investigación Clínica S.C | Monterrey | 64710 | Mexico |
| Hospital Universitario de Saltillo | Saltillo | 25000 | Mexico |
| Podlaskie Centrum Psychogeriatrii | Bialystok | 15-756 | Poland |
| NZOZ NEURO-KARD Ilkowski i Partnerzy Sp. Partn. Lek | Poznan | 61-853 | Poland |
| NEURO-CARE Sp. z o.o. Sp. Komandytowa | Siemianowice Śląskie | 41-100 | Poland |
| Przychodnia Specjalistyczna PROSEN | Warsaw | 01-231 | Poland |
| Centrum Medyczne NeuroProtect | Warsaw | 01-684 | Poland |
| Optimum | Warsaw | 01-785 | Poland |
| Hospital Prof. Dr. Fernando Fonseca; Servico de Neurologia | Amadora | 2720-276 | Portugal |
| Hospital Beatriz Angelo; Servico de Neurologia | Loures | 2674-514 | Portugal |
| State Autonomous Healthcare Institution "Republican Clinical Neurological Center | Kazan' | 420021 | Russia |
| State autonomous institution of healthcare Inter-regional clinical and diagnostic center | Kazan' | 420101 | Russia |
| Institution of RAMS (Mental Health Research Center of RAMS) | Moscow | 115522 | Russia |
| SBEI of HPI The 1st Moscow State Medical University n.a. I.M. Sechenov of MOH of RF | Moscow | 119021 | Russia |
| SHI City Psychoneurological Dispensary #7 | Saint Petersburg | 190005 | Russia |
| Russian Medical Military Academy n.a. S.M.Kirov; Neurology Department | Saint Petersburg | 194044 | Russia |
| City Clinical Hospital # 2 n.a. V.I. Razumovsky | Saratov | 410028 | Russia |
| University Medical Centre Maribor | Maribor | 2000 | Slovenia |
| Chonnam National University Hospital | Gwangju | 61469 | South Korea |
| Inha University Hospital | Incheon | 22332 | South Korea |
| Konkuk University Medical Center | Seoul | 05030 | South Korea |
| Asan Medical Center | Seoul | 05505 | South Korea |
| KyungHee Medical Center | Seoul | 130-702 | South Korea |
| Ewha Womans University Mokdong Hospital; Dept of Neurology | Seoul | 158-710 | South Korea |
| Fundació ACE | BArcelon | Barcelona | 08034 | Spain |
| Hospital Universitari de Bellvitge; Servicio de Neurologia | L'Hospitalet de Llobregat | Barcelona | 08907 | Spain |
| Hospital Sant Joan de Deu; Servicio de Neurología | Manresa | Barcelona | Spain |
| Hospital General De Catalunya; Servicio de Neurologia | Sant Cugat del Vallès | Barcelona | 8195 | Spain |
| Hospital Mutua De Terrasa; Servicio de Neurologia | Terrassa | Barcelona | 08222 | Spain |
| Hospital Virgen del Puerto. Servicio de Neurología | Plasencia | Caceres | 10600 | Spain |
| Hospital Universitario Marques de Valdecilla; Servicio de Neurología | Santander | Cantabria | Spain |
| Clinica Universitaria de Navarra; Servicio de Neurología | Pamplona | Navarre | 31008 | Spain |
| Complejo Asistencial Universitario de Salamanca; Servicio de Psiquiatría | Salamaca | Salamanca | 37007 | Spain |
| Hospital General Universitario de Albacete; Servicio de Neurología | Albacete | Spain |
| Hospital Vall d'Hebron; Servicio de Neurología | Barcelona | 08035 | Spain |
| Hospital Universitario de Burgos. Servicio de Neurología | Burgos | 09006 | Spain |
| Clinica Ruber, 4 planta; Servicio de Neurologia | Madrid | 28006 | Spain |
| Universitario de La Princesa; Servicio de Neurología | Madrid | 28006 | Spain |
| Hospital Universitario 12 de Octubre; Servicio de Neurologia | Madrid | 28041 | Spain |
| Hospital Regional Universitario Carlos Haya; Servicio de Neurologia | Málaga | 29010 | Spain |
| Hospital Universitario Virgen de Arrixaca; Servicio de Neurología | Murcia | Spain |
| Hospital Universitario la Fe; Servicio de Neurologia | Valencia | 46026 | Spain |
| Servicio de Neurología Hospital Viamed Montecanal. | Zaragoza | 50012 | Spain |
| Skånes Universitetssjukhus Malmö, Minneskliniken | Malmö | 211 46 | Sweden |
| Sahlgrenska Academy University,Neuroscience and Physiology;Departmt of Psychiatry and Neurochemistry | Mölndal | 431 41 | Sweden |
| Karolinska Uni Hospital, Huddinge; Dept. of Geriatric Med | Stockholm | 14186 | Sweden |
| Universitäres Zentrum für Altersmedizin und Rehabilitation | Basel | 4002 | Switzerland |
| Hacettepe University School of Medicine; Neurology | Ankara | 06100 | Turkey (Türkiye) |
| Osmangazi University School of Medicine,Neurology Department | Eskişehir | 26480 | Turkey (Türkiye) |
| Istanbul University Istanbul School of Medicine; Neurology | Istanbul | 34093 | Turkey (Türkiye) |
| Ondokuz Mayis University School of Medicine; Neurology | Samsun | 55139 | Turkey (Türkiye) |
| Regional mental hospital; Department of psychiatry, psychology and sexology | Lviv | KIEV Governorate | 79021 | Ukraine |
| National Medical Academy of Postgraduate Education named after P.L.Shupik; Neurology Department #1 | Kiev | 04112 | Ukraine |
| D.F.Chebotarev Institute of Gerontology NAMS;Depart of Age Physiology&Pathology of Nervous System | Kiev | 04114 | Ukraine |
| Royal Preston Hospital | Blackburn | PR2 9HT | United Kingdom |
| Surrey and Borders NHS Foundation Trust; Brain Science Research Unit | Chertsey | KT16 0AE | United Kingdom |
| Coventry and Warwickshire Partnership NHS Trust | Coventry | CV6 6NY | United Kingdom |
| St George's Hospital | London | SW17 0QT | United Kingdom |
| Charing Cross Hospital | London | W6 8RF | United Kingdom |
| Manchester Royal Infirmary | Manchester | M13 9WL | United Kingdom |
| Campus for Ageing and Vitality | Newcastle upon Tyne | NE4 6BE | United Kingdom |
| John Radcliffe Hospital | Oxford | OX3 9DU | United Kingdom |
| Chandler JM, Lansdall CJ, Ye W, McDougall F, Belger M, Toth B, Mi X, Sink KM, Atkins AS. The Alzheimer's Disease Cooperative Study - Activities of Daily Living dependence score: revision and validation of an algorithm evaluating patient dependence across the spectrum of AD severity. J Prev Alzheimers Dis. 2025 Sep;12(8):100261. doi: 10.1016/j.tjpad.2025.100261. Epub 2025 Jul 1. |
| 36641609 | Derived | Teng E, Manser PT, Shah M, Pickthorn K, Hu N, Djakovic S, Swendsen H, Blendstrup M, Faccin G, Ostrowitzki S, Sink KM. The Use of Episodic Memory Tests for Screening in Clinical Trials for Early Alzheimer's Disease: A Comparison of the Free and Cued Selective Reminding Test (FCSRT) and the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS). J Prev Alzheimers Dis. 2023;10(1):41-49. doi: 10.14283/jpad.2022.101. |
| 36121669 | Derived | Ostrowitzki S, Bittner T, Sink KM, Mackey H, Rabe C, Honig LS, Cassetta E, Woodward M, Boada M, van Dyck CH, Grimmer T, Selkoe DJ, Schneider A, Blondeau K, Hu N, Quartino A, Clayton D, Dolton M, Dang Y, Ostaszewski B, Sanabria-Bohorquez SM, Rabbia M, Toth B, Eichenlaub U, Smith J, Honigberg LA, Doody RS. Evaluating the Safety and Efficacy of Crenezumab vs Placebo in Adults With Early Alzheimer Disease: Two Phase 3 Randomized Placebo-Controlled Trials. JAMA Neurol. 2022 Nov 1;79(11):1113-1121. doi: 10.1001/jamaneurol.2022.2909. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Participants received intravenous (IV) infusion of Placebo every 4 weeks (Q4W) for 100 weeks. |
| BG001 | Crenezumab | Participants received intravenous (IV) infusion of Crenezumab every 4 weeks (Q4W) for 100 weeks. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Number | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Number | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline to Week 105 in Clinical Dementia Rating-Sum of Boxes (CDR-SB) Score | The CDR-SB rates impairment in 6 categories (memory, orientation, judgement and problem solving, community affairs, home and hobbies and personal care) on a 5-point scale in which no impairment = 0, questionable impairment = 0.5 and mild, moderate and severe impairment = 1, 2 and 3 respectively. The score range is from 0 to 18 with a high score indicating a high disease severity. The difference in mean change from Baseline to Week 105 between Crenezumab and Placebo treated participants was estimated. Mixed model repeated measures (MMRMs) adjusting for disease severity, APOEe4 status, geographic region and the use or non-use of anti-dementia medications at baseline were used to estimate the mean change from baseline for this primary endpoint. Data after 29 January 2019 are censored for the primary and secondary efficacy analyses to avoid potential biases due to investigators, participants, raters, etc. being potentially influenced by early closure of the study due to lack of efficacy. | The Modified Intent-To-Treat population (Placebo (n = 407); Cren (n = 402)) was defined as all randomized participants who received at least 1 dose of study drug, with participants grouped according to the treatment assigned at randomization. Data presented below is only for participants that were included in the actual analysis. | Posted | Least Squares Mean | Standard Error | Units on a Scale | Baseline, Week 105 |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline to Week 105 on Cognition, as Assessed by Alzheimer's Disease Assessment Scale-Cognition (ADAS-Cog) (Subscale) 13 (ADAS-Cog-13) | The ADAS-Cog-13 assesses multiple cognitive domains including memory, comprehension, praxis, orientation, and spontaneous speech. Most of these are assessed by tests although some are rated by the clinician on a 5-point scale. The ADAS-Cog-13 is the ADAS-Cog-11 with 2 further items: delayed word recall and total digit cancellation. The score range for ADAS-Cog-13 is from 0 to 85 with high scores representing severe dysfunction. The difference in mean change from Baseline to Week 105 between Crenezumab and Placebo treated participants was estimated. Mixed model repeated measures (MMRMs) adjusting for disease severity, APOEe4 status, geographic region, and the use or non-use of anti-dementia medications at baseline were used to estimate the mean change from baseline. | The Modified Intent-To-Treat population (Placebo (n = 407); Cren (n = 402)) was defined as all randomized participants who received at least 1 dose of study drug, with participants grouped according to the treatment assigned at randomization. Data presented below is only for participants that were included in the actual analysis. | Posted | Least Squares Mean | Standard Error | Units on a Scale | Baseline, Week 105 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline to Week 105 on Cognition, as Assessed by Alzheimer's Disease Assessment Scale-Cognition (ADAS-Cog) (Subscale) 11 (ADAS-Cog-11) | The ADAS-Cog-11 assesses multiple cognitive domains including memory, comprehension, praxis, orientation, and spontaneous speech. Most of these are assessed by tests although some are rated by the clinician on a 5-point scale. The score range for ADAS-Cog-11 is from 0 to 70 with high scores representing severe dysfunction. The difference in mean change from Baseline to Week 105 between Crenezumab and Placebo treated participants was estimated. Mixed model repeated measures (MMRMs) adjusting for disease severity, APOEe4 status, geographic region, and the use or non-use of anti-dementia medications at baseline were used to estimate the mean change from baseline. | The Modified Intent-To-Treat population (Placebo (n = 407); Cren (n = 402)) was defined as all randomized participants who received at least 1 dose of study drug, with participants grouped according to the treatment assigned at randomization. Data presented below is only for participants that were included in the actual analysis. | Posted | Least Squares Mean | Standard Error | Units on a Scale | Baseline, Week 105 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline to Week 105 on Severity of Dementia, Assessed Using the CDR-Global Score (CDR-GS) | The CDR-GS represents a semi-structured interview which rates impairment in 6 categories (memory, orientation, judgement and problem solving, community affairs, home and hobbies, and personal care) on a 5-point scale in which CDR 0 = no dementia and CDR 0.5, 1, 2 or 3 = questionable, mild, moderate or severe dementia respectively. The range in scores for the CDR-GS is from 0 to 3 and a high score on the CDR-GS would indicate a high disease severity. The difference in mean change from Baseline to Week 105 between Crenezumab and Placebo treated participants was estimated. Mixed model repeated measures (MMRMs) adjusting for disease severity, APOEe4 status, geographic region, and the use or non-use of anti-dementia medications at baseline were used to estimate the mean change from baseline. | The Modified Intent-To-Treat population (Placebo (n = 407); Cren (n = 402)) was defined as all randomized participants who received at least 1 dose of study drug, with participants grouped according to the treatment assigned at randomization. Data presented below is only for participants that were included in the actual analysis. | Posted | Least Squares Mean | Standard Error | Units on a Scale | Baseline, Week 105 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline to Week 105 on Severity of Dementia, Assessed Using the Mini Mental State Evaluation (MMSE) | The MMSE is a set of standardized questions used to evaluate possible cognitive impairment and help stage the severity level of this impairment. The questions target 6 areas: orientation, registration, attention, short-term recall, language and constructional praxis/visuospatial abilities. The scores on the MMSE range from 0 to 30, with higher scores indicating better function. The difference in mean change from Baseline to Week 105 between Crenezumab and Placebo treated participants was estimated. Mixed model repeated measures (MMRMs) adjusting for disease severity, APOEe4 status, geographic region, and the use or non-use of anti-dementia medications at baseline were used to estimate the mean change from baseline. | The Modified Intent-To-Treat population (Placebo (n = 407); Cren (n = 402)) was defined as all randomized participants who received at least 1 dose of study drug, with participants grouped according to the treatment assigned at randomization. Data presented below is only for participants that were included in the actual analysis. | Posted | Least Squares Mean | Standard Error | Units on a Scale | Baseline, Week 105 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline to Week 105 on Function as Assessed by the ADCS-ADL Total Score | The ADCS-ADL (Alzheimer's Disease Cooperative Study-Activities of Daily Living) is the scale most widely used to assess functional outcomes in participants with AD. The ADCS-ADL covers both basic ADL (e.g., eating and toileting) and more complex 'instrumental' ADL or iADL (e.g., using the telephone, managing finances and preparing a meal). The ADCS-ADL consists of 23 questions with a score range of 0 to 78 where a higher score represents better function. The difference in mean change from Baseline to Week 105 between Crenezumab and Placebo treated participants was estimated. Mixed model repeated measures (MMRMs) adjusting for disease severity, APOEe4 status, geographic region, and the use or non-use of anti-dementia medications at baseline were used to estimate the mean change from baseline. | The Modified Intent-To-Treat population (Placebo (n = 407); Cren (n = 402)) was defined as all randomized participants who received at least 1 dose of study drug, with participants grouped according to the treatment assigned at randomization. Data presented below is only for participants that were included in the actual analysis. | Posted | Least Squares Mean | Standard Error | Units on a Scale | Baseline, Week 105 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline to Week 105 on Function as Assessed by the ADCS-instrumental (ADCS-iADL) Subscore | The ADCS-iADL (Alzheimer's Disease Cooperative Study-Instrumental Activities of Daily Living) measures activities such as using the telephone, managing finances and preparing a meal. The ADCS-iADL consists of 16 questions with a score range of 0 to 56 where a higher score represents better function. The difference in mean change from Baseline to Week 105 between Crenezumab and Placebo treated participants was estimated. Mixed model repeated measures (MMRMs) adjusting for disease severity, APOEe4 status, geographic region, and the use or non-use of anti-dementia medications at baseline were used to estimate the mean change from baseline. | The Modified Intent-To-Treat population (Placebo (n = 407); Cren (n = 402)) was defined as all randomized participants who received at least 1 dose of study drug, with participants grouped according to the treatment assigned at randomization. Data presented below is only for participants that were included in the actual analysis. | Posted | Least Squares Mean | Standard Error | Units on a Scale | Baseline, Week 105 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline to Week 105 on a Measure of Dependence Derived From the ADCS-ADL Score | The ADCS-ADL (Alzheimer's Disease Cooperative Study-Activities of Daily Living) is the scale most widely used to assess functional outcomes in participants with AD. The ADCS-ADL covers both basic ADL (e.g., eating and toileting) and more complex 'instrumental' ADL or iADL (e.g., using the telephone, managing finances and preparing a meal). The ADCS-ADL consists of 23 questions with a score range of 0 to 78 where a higher score represents better function. The difference in mean change from Baseline to Week 105 between Crenezumab and Placebo treated participants was estimated. Mixed model repeated measures (MMRMs) adjusting for disease severity, APOEe4 status, geographic region, and the use or non-use of anti-dementia medications at baseline were used to estimate the mean change from baseline. | Please note that for this Outcome Measure, no participants were evaluated at all as the derivation of this endpoint was not pre-specified before the Sponsor terminated the study and therefore it was not reported. | Posted | Baseline, Week 105 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline to Week 105 Assessed Using the Neuropsychiatric Inventory Questionnaire (NPI-Q) | The NPI-Q is an informant-based instrument that evaluates 12 neuropsychiatric disturbances common in dementia: delusions, hallucinations, agitation, dysphoria, anxiety, apathy, irritability, euphoria, disinhibition, aberrant motor behavior, night-time behavioral disturbances and appetite and eating abnormalities. The severity of each neuropsychiatric symptom is rated on a 3-point scale (mild, moderate and marked). The total severity score range is from 0 to 36 with higher scores representing higher severity. The difference in mean change from Baseline to Week 105 between Crenezumab and Placebo treated participants was estimated. Mixed model repeated measures (MMRMs) adjusting for disease severity, APOEe4 status, geographic region, and the use or non-use of anti-dementia medications at baseline were used to estimate the mean change from baseline. | The Modified Intent-To-Treat population (Placebo (n = 407); Cren (n = 402)) was defined as all randomized participants who received at least 1 dose of study drug, with participants grouped according to the treatment assigned at randomization. Data presented below is only for participants that were included in the actual analysis. | Posted | Least Squares Mean | Standard Error | Units on a Scale | Baseline, Week 105 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Quality of Life-Alzheimer's Disease (QoL-AD) Scale Score | The QoL-AD (Quality of Life - Alzheimer's Disease) scale assesses QoL in participants who have dementia. The QoL-AD consists of 13 items covering aspects of participants' relationships with friends and family, physical condition, mood, concerns about finances and overall assessment of QoL. Items are rated on 4-point Likert-type scales ranging from 1 [poor] to 4 [excellent]. The score range is from 13 to 52, with higher scores indicating a better QoL. The difference in mean change from Baseline to Week 105 between Crenezumab and Placebo treated participants was estimated. Mixed model repeated measures (MMRMs) adjusting for disease severity, APOEe4 status, geographic region, and the use or non-use of anti-dementia medications at baseline were used to estimate the mean change from baseline. | The Modified Intent-To-Treat population (Placebo (n = 407); Cren (n = 402)) was defined as all randomized participants who received at least 1 dose of study drug, with participants grouped according to the treatment assigned at randomization. Data presented below is only for participants that were included in the actual analysis. | Posted | Least Squares Mean | Standard Error | Units on a Scale | Baseline up to Week 105 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Zarit Caregiver Interview for Alzheimer's Disease (ZCI-AD) Scale Score | The ZCI-AD is a modified version of the Zarit Burden Interview, which was originally designed to reflect the stresses experienced by caregivers of people with dementia. This modified version includes slight modifications in item and title wording (e.g., removal of "your relative" to refer directly to the patient, removal of "burden" from title) and the use of 11-point numerical rating scales. The ZCI-AD scale consists of a total of 30 items. Total scores will be calculated with a total score range from 0 to 300 (higher scores indicate a higher burden on the caregiver). The difference in mean change from Baseline to Week 105 between Crenezumab and Placebo treated participants was estimated. Mixed model repeated measures (MMRMs) adjusting for disease severity, APOEe4 status, geographic region, and the use or non-use of anti-dementia medications at baseline were used to estimate the mean change from baseline. | The Modified Intent-To-Treat population (Placebo (n = 407); Cren (n = 402)) was defined as all randomized participants who received at least 1 dose of study drug, with participants grouped according to the treatment assigned at randomization. Data presented below is only for participants that were included in the actual analysis. | Posted | Least Squares Mean | Standard Error | Units on a Scale | Baseline up to Week 105 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | EQ-5D Questionnaire Domain Score for Participants | The EQ-5D is a standardized measure of health status designed to provide a simple generic measure of health for clinical and economic appraisal. It is broadly applicable across a wide range of health conditions and treatment. The EQ-5D assesses five domains to provide a health state index. These are anxiety/depression, pain/discomfort, usual activities, mobility, and self-care. The scores on the EQ-5D ranges from 0 (worst imaginable health state) to 100 (best imaginable health state). The difference in mean change from Baseline to Week 105 between Crenezumab and Placebo treated participants was estimated. Mixed model repeated measures (MMRMs) adjusting for disease severity, APOEe4 status, geographic region, and the use or non-use of anti-dementia medications at baseline were used to estimate the mean change from baseline. | The Modified Intent-To-Treat population (Placebo (n = 407); Cren (n = 402)) was defined as all randomized participants who received at least 1 dose of study drug, with participants grouped according to the treatment assigned at randomization. Data presented below is only for participants that were included in the actual analysis. | Posted | Least Squares Mean | Standard Error | Units on a Scale | Baseline up to Week 105 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | EQ-5D Questionnaire Domain Score for Caregivers | The EQ-5D is a standardized measure of health status designed to provide a simple generic measure of health for clinical and economic appraisal. It is broadly applicable across a wide range of health conditions and treatment. The EQ-5D assesses five domains to provide a health state index. These are anxiety/depression, pain/discomfort, usual activities, mobility, and self-care. The scores on the EQ-5D ranges from 0 (worst imaginable health state) to 100 (best imaginable health state). The difference in mean change from Baseline to Week 105 between Crenezumab and Placebo treated participants was estimated. Mixed model repeated measures (MMRMs) adjusting for disease severity, APOEe4 status, geographic region, and the use or non-use of anti-dementia medications at baseline were used to estimate the mean change from baseline. | The Modified Intent-To-Treat population (Placebo (n = 407); Cren (n = 402)) was defined as all randomized participants who received at least 1 dose of study drug, with participants grouped according to the treatment assigned at randomization. Data presented below is only for participants that were included in the actual analysis. | Posted | Least Squares Mean | Standard Error | Units on a Scale | Baseline up to Week 105 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Adverse Event (AEs) and Serious Adverse Event (SAEs) | An Adverse Event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events. | The Safety analysis population included all randomized participants who received at least 1 dose of study drug with participants grouped according to actual treatment received. If a participant received at least 2 vials of crenezumab, then they were placed in the crenezumab arm. | Posted | Number | Percentage | Baseline up until 16 weeks after the last dose of study drug (up to 117 weeks). |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Anti-Crenezumab Antibodies | Participants were considered positive or negative for ADA based on their baseline and post-baseline sample results. The number and percentage of participants with confirmed positive ADA levels were determined for Crenezumab and Placebo groups. The prevalence of ADA at baseline was calculated as the proportion of participants with confirmed positive ADA levels at baseline relative to the total number of participants with a sample available at baseline. The incidence of treatment-emergent ADAs was determined as the proportion of participants with confirmed post-baseline positive ADAs relative to the total number of participants that had at least one post-baseline sample available for ADA analysis. | The Safety analysis population included all randomized participants who received at least 1 dose of study drug with participants grouped according to actual treatment received. If a participant received at least 2 vials of crenezumab, then they were placed in the crenezumab arm. Data below is only for participants included in the actual analysis. | Posted | Number | Percentage | Baseline up to Week 105 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Serum Concentration of Crenezumab | Serum concentration data for Crenezumab will be tabulated and summarized. Descriptive summary statistics will include the arithmetic mean and SD. Since a sparse PK sampling design is being used, population (non-linear mixed-effects) modeling will be used to analyze the dose concentration-time data of crenezumab. Information from other clinical studies may be incorporated to establish the PK model. Please note that Post-dose samples were not collected at Weeks 37 and 105. | The PK Analysis population was defined as all participants who have received at least one dose of crenezumab and with at least one evaluable post-dose PK sample. Data presented below is only for participants that were included in the actual analysis. | Posted | Mean | Standard Deviation | ug/mL | Pre-infusion (0 hour), 60-90 minutes post-infusion on Day 1 Week 1 and on Week 25; Weeks 13, 37 (Pre-dose), 53, 77 and 105 (infusion length = as per the Pharmacy Manual) |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Plasma Amyloid Beta (Abeta) 40 Concentrations | Plasma Abeta 40 concentrations will be measured over time and descriptive summary statistics will include the arithmetic mean and SD. Please note that a Post-dose sample was only collected at Week 13. | The PD Analysis population was defined as all participants who have received at least one dose of crenezumab and with at least one evaluable post-dose PK sample. Data presented below is only for participants that were included in the actual analysis. | Posted | Mean | Standard Deviation | ng/mL | Week 1 Day 1; Weeks 13, 25, 53, 77 and 105 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Plasma Amyloid Beta (Abeta) 42 Concentrations | Plasma Abeta 42 concentrations will be measured over time and descriptive summary statistics will include the arithmetic mean and SD. Please note that a Post-dose sample was only collected at Week 13. | The PD Analysis population was defined as all participants who have received at least one dose of crenezumab and with at least one evaluable post-dose PK sample. Data presented below is only for participants that were included in the actual analysis. | Posted | Mean | Standard Deviation | ng/mL | Week 1 Day 1; Weeks 13, 25, 53, 77 and 105 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage Change From Baseline to Week 105 in Whole Brain Volume as Determined by Magnetic Resonance Imaging (MRI) | Percentage Change in Whole Brain Volume will be measured over time and descriptive summary statistics will include the arithmetic mean, median, range, SD, and coefficient of variation, as appropriate. Mixed model repeated measures (MMRMs) adjusting for disease severity, APOEe4 status, geographic region, and the use or non-use of anti-dementia medications at baseline were used to estimate the mean change from baseline. | The Modified Intent-To-Treat population (Placebo (n = 407); Cren (n = 402)) was defined as all randomized participants who received at least 1 dose of study drug, with participants grouped according to the treatment assigned at randomization. Data presented below is only for participants that were included in the actual analysis. | Posted | Least Squares Mean | Standard Error | Percentage | Baseline, Week 105 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage Change From Baseline to Week 105 in Ventricle Volume as Determined by Magnetic Resonance Imaging (MRI) | Percentage Change in Ventricle Volume will be measured over time and descriptive summary statistics will include the arithmetic mean, median, range, SD, and coefficient of variation, as appropriate. Mixed model repeated measures (MMRMs) adjusting for disease severity, APOEe4 status, geographic region, and the use or non-use of anti-dementia medications at baseline were used to estimate the mean change from baseline. | The Modified Intent-To-Treat population (Placebo (n = 407); Cren (n = 402)) was defined as all randomized participants who received at least 1 dose of study drug, with participants grouped according to the treatment assigned at randomization. Data presented below is only for participants that were included in the actual analysis. | Posted | Least Squares Mean | Standard Error | Percentage | Baseline, Week 105 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage Change From Baseline to Week 105 in Hippocampal Volume as Determined by Magnetic Resonance Imaging (MRI) | Percentage Change in Hippocampal Volume will be measured over time and descriptive summary statistics will include the arithmetic mean, median, range, SD, and coefficient of variation, as appropriate. Mixed model repeated measures (MMRMs) adjusting for disease severity, APOEe4 status, geographic region, and the use or non-use of anti-dementia medications at baseline were used to estimate the mean change from baseline. | The Modified Intent-To-Treat population (Placebo (n = 407); Cren (n = 402)) was defined as all randomized participants who received at least 1 dose of study drug, with participants grouped according to the treatment assigned at randomization. Data presented below is only for participants that were included in the actual analysis. | Posted | Least Squares Mean | Standard Error | Percentage | Baseline, Week 105 |
|
|
Baseline up until 16 weeks after the last dose of study drug (up to 117 weeks).
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Participants received intravenous (IV) infusion of Placebo every 4 weeks (Q4W) for 100 weeks. | 5 | 405 | 63 | 405 | 214 | 405 |
| EG001 | Crenezumab | Participants received intravenous (IV) infusion of Crenezumab every 4 weeks (Q4W) for 100 weeks. | 8 | 404 | 67 | 404 | 225 | 404 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ACUTE CORONARY SYNDROME | Cardiac disorders | MedDRA 22.0 | Systematic Assessment |
| |
| ANGINA UNSTABLE | Cardiac disorders | MedDRA 22.0 | Systematic Assessment |
| |
| ATRIAL FLUTTER | Cardiac disorders | MedDRA 22.0 | Systematic Assessment |
| |
| ATRIOVENTRICULAR BLOCK COMPLETE | Cardiac disorders | MedDRA 22.0 | Systematic Assessment |
| |
| BRADYCARDIA | Cardiac disorders | MedDRA 22.0 | Systematic Assessment |
| |
| CARDIAC ARREST | Cardiac disorders | MedDRA 22.0 | Systematic Assessment |
| |
| CARDIAC FAILURE ACUTE | Cardiac disorders | MedDRA 22.0 | Systematic Assessment |
| |
| CORONARY ARTERY DISEASE | Cardiac disorders | MedDRA 22.0 | Systematic Assessment |
| |
| MYOCARDIAL INFARCTION | Cardiac disorders | MedDRA 22.0 | Systematic Assessment |
| |
| MYOCARDIAL ISCHAEMIA | Cardiac disorders | MedDRA 22.0 | Systematic Assessment |
| |
| VERTIGO | Ear and labyrinth disorders | MedDRA 22.0 | Systematic Assessment |
| |
| AUTOIMMUNE THYROIDITIS | Endocrine disorders | MedDRA 22.0 | Systematic Assessment |
| |
| HYPERPARATHYROIDISM PRIMARY | Endocrine disorders | MedDRA 22.0 | Systematic Assessment |
| |
| ABDOMINAL DISCOMFORT | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| ABDOMINAL PAIN UPPER | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| CHRONIC GASTRITIS | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| COLITIS | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| COLITIS ISCHAEMIC | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| CONSTIPATION | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| DIVERTICULUM | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| GASTROINTESTINAL HAEMORRHAGE | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| GASTROINTESTINAL PERFORATION | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| GASTROINTESTINAL ULCER HAEMORRHAGE | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| GASTROINTESTINAL VASCULAR MALFORMATION | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| GASTROOESOPHAGEAL REFLUX DISEASE | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| INGUINAL HERNIA | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| LOWER GASTROINTESTINAL HAEMORRHAGE | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| RECTAL HAEMORRHAGE | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| CHEST PAIN | General disorders | MedDRA 22.0 | Systematic Assessment |
| |
| DEATH | General disorders | MedDRA 22.0 | Systematic Assessment |
| |
| NON-CARDIAC CHEST PAIN | General disorders | MedDRA 22.0 | Systematic Assessment |
| |
| CHOLECYSTITIS ACUTE | Hepatobiliary disorders | MedDRA 22.0 | Systematic Assessment |
| |
| CHOLELITHIASIS | Hepatobiliary disorders | MedDRA 22.0 | Systematic Assessment |
| |
| ANAPHYLACTIC REACTION | Immune system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| APPENDICITIS | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| CELLULITIS | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| DIVERTICULITIS | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| ERYSIPELAS | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| HERPES ZOSTER | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| PERITONITIS | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| PERITONSILLAR ABSCESS | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| PNEUMONIA | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| PNEUMONIA BACTERIAL | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| PYELONEPHRITIS | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| SKIN INFECTION | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| TUBERCULOSIS OF CENTRAL NERVOUS SYSTEM | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| URINARY TRACT INFECTION | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| UROSEPSIS | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| VIRAL INFECTION | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| CLAVICLE FRACTURE | Injury, poisoning and procedural complications | MedDRA 22.0 | Systematic Assessment |
| |
| CONCUSSION | Injury, poisoning and procedural complications | MedDRA 22.0 | Systematic Assessment |
| |
| FACIAL BONES FRACTURE | Injury, poisoning and procedural complications | MedDRA 22.0 | Systematic Assessment |
| |
| FALL | Injury, poisoning and procedural complications | MedDRA 22.0 | Systematic Assessment |
| |
| FEMUR FRACTURE | Injury, poisoning and procedural complications | MedDRA 22.0 | Systematic Assessment |
| |
| HIP FRACTURE | Injury, poisoning and procedural complications | MedDRA 22.0 | Systematic Assessment |
| |
| RADIUS FRACTURE | Injury, poisoning and procedural complications | MedDRA 22.0 | Systematic Assessment |
| |
| RIB FRACTURE | Injury, poisoning and procedural complications | MedDRA 22.0 | Systematic Assessment |
| |
| ROAD TRAFFIC ACCIDENT | Injury, poisoning and procedural complications | MedDRA 22.0 | Systematic Assessment |
| |
| SKIN LACERATION | Injury, poisoning and procedural complications | MedDRA 22.0 | Systematic Assessment |
| |
| SKULL FRACTURED BASE | Injury, poisoning and procedural complications | MedDRA 22.0 | Systematic Assessment |
| |
| SOFT TISSUE INJURY | Injury, poisoning and procedural complications | MedDRA 22.0 | Systematic Assessment |
| |
| SUBDURAL HAEMATOMA | Injury, poisoning and procedural complications | MedDRA 22.0 | Systematic Assessment |
| |
| SUBDURAL HAEMORRHAGE | Injury, poisoning and procedural complications | MedDRA 22.0 | Systematic Assessment |
| |
| TRAUMATIC INTRACRANIAL HAEMORRHAGE | Injury, poisoning and procedural complications | MedDRA 22.0 | Systematic Assessment |
| |
| ULNA FRACTURE | Injury, poisoning and procedural complications | MedDRA 22.0 | Systematic Assessment |
| |
| UPPER LIMB FRACTURE | Injury, poisoning and procedural complications | MedDRA 22.0 | Systematic Assessment |
| |
| WRIST FRACTURE | Injury, poisoning and procedural complications | MedDRA 22.0 | Systematic Assessment |
| |
| DEHYDRATION | Metabolism and nutrition disorders | MedDRA 22.0 | Systematic Assessment |
| |
| DIABETIC KETOACIDOSIS | Metabolism and nutrition disorders | MedDRA 22.0 | Systematic Assessment |
| |
| ARTHRALGIA | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | Systematic Assessment |
| |
| ARTHRITIS | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | Systematic Assessment |
| |
| INTERVERTEBRAL DISC PROTRUSION | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | Systematic Assessment |
| |
| LUMBAR SPINAL STENOSIS | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | Systematic Assessment |
| |
| OSTEOARTHRITIS | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | Systematic Assessment |
| |
| SYSTEMIC SCLERODERMA | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | Systematic Assessment |
| |
| ADENOCARCINOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22.0 | Systematic Assessment |
| |
| ADENOCARCINOMA GASTRIC | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22.0 | Systematic Assessment |
| |
| BREAST CANCER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22.0 | Systematic Assessment |
| |
| DIFFUSE LARGE B-CELL LYMPHOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22.0 | Systematic Assessment |
| |
| INVASIVE DUCTAL BREAST CARCINOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22.0 | Systematic Assessment |
| |
| LUNG ADENOCARCINOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22.0 | Systematic Assessment |
| |
| LUNG NEOPLASM MALIGNANT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22.0 | Systematic Assessment |
| |
| LYMPHOPROLIFERATIVE DISORDER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22.0 | Systematic Assessment |
| |
| PROSTATE CANCER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22.0 | Systematic Assessment |
| |
| CAROTID ARTERY STENOSIS | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| CENTRAL NERVOUS SYSTEM LESION | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| CEREBRAL HAEMORRHAGE | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| CEREBRAL ISCHAEMIA | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| CEREBROVASCULAR ACCIDENT | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| CEREBROVASCULAR DISORDER | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| DEMENTIA ALZHEIMER'S TYPE | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| DEPRESSED LEVEL OF CONSCIOUSNESS | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| HYDROCEPHALUS | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| ISCHAEMIC STROKE | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| LOSS OF CONSCIOUSNESS | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| PARAESTHESIA | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| SEIZURE | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| SUBARACHNOID HAEMORRHAGE | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| SYNCOPE | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| DEVICE FAILURE | Product Issues | MedDRA 22.0 | Systematic Assessment |
| |
| ACUTE PSYCHOSIS | Psychiatric disorders | MedDRA 22.0 | Systematic Assessment |
| |
| AGITATION | Psychiatric disorders | MedDRA 22.0 | Systematic Assessment |
| |
| DELIRIUM | Psychiatric disorders | MedDRA 22.0 | Systematic Assessment |
| |
| DELUSION | Psychiatric disorders | MedDRA 22.0 | Systematic Assessment |
| |
| HALLUCINATION, VISUAL | Psychiatric disorders | MedDRA 22.0 | Systematic Assessment |
| |
| PERSONALITY CHANGE | Psychiatric disorders | MedDRA 22.0 | Systematic Assessment |
| |
| SCHIZOPHRENIA | Psychiatric disorders | MedDRA 22.0 | Systematic Assessment |
| |
| ACUTE KIDNEY INJURY | Renal and urinary disorders | MedDRA 22.0 | Systematic Assessment |
| |
| NEPHROLITHIASIS | Renal and urinary disorders | MedDRA 22.0 | Systematic Assessment |
| |
| OVARIAN CYST | Reproductive system and breast disorders | MedDRA 22.0 | Systematic Assessment |
| |
| ACUTE INTERSTITIAL PNEUMONITIS | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| PNEUMONIA ASPIRATION | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| PULMONARY EMBOLISM | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| ANGIOEDEMA | Skin and subcutaneous tissue disorders | MedDRA 22.0 | Systematic Assessment |
| |
| CORONARY ARTERY BYPASS | Surgical and medical procedures | MedDRA 22.0 | Systematic Assessment |
| |
| SKIN NEOPLASM EXCISION | Surgical and medical procedures | MedDRA 22.0 | Systematic Assessment |
| |
| URETHRAL STENT INSERTION | Surgical and medical procedures | MedDRA 22.0 | Systematic Assessment |
| |
| HYPOTENSION | Vascular disorders | MedDRA 22.0 | Systematic Assessment |
| |
| PERIPHERAL ARTERIAL OCCLUSIVE DISEASE | Vascular disorders | MedDRA 22.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| DIARRHOEA | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| BRONCHITIS | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| NASOPHARYNGITIS | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| URINARY TRACT INFECTION | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| FALL | Injury, poisoning and procedural complications | MedDRA 22.0 | Systematic Assessment |
| |
| WEIGHT DECREASED | Investigations | MedDRA 22.0 | Systematic Assessment |
| |
| BACK PAIN | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | Systematic Assessment |
| |
| DIZZINESS | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| HEADACHE | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| ANXIETY | Psychiatric disorders | MedDRA 22.0 | Systematic Assessment |
| |
| DEPRESSION | Psychiatric disorders | MedDRA 22.0 | Systematic Assessment |
| |
| RASH | Skin and subcutaneous tissue disorders | MedDRA 22.0 | Systematic Assessment |
| |
| HYPERTENSION | Vascular disorders | MedDRA 22.0 | Systematic Assessment |
|
The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Communications | Hoffmann-La Roche | 800 821-8590 | genentech@druginfo.com |
| May 26, 2020 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D024801 | Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| C573372 | crenezumab |
Not provided
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Not Stated |
|
| Unknown |
|
| Asian |
|
| Black or African American |
|
| Multiple |
|
| Unknown |
|
| White |
|
Participants received intravenous (IV) infusion of Crenezumab every 4 weeks (Q4W) for 100 weeks.
|
|
|
|
|
|
Participants received intravenous (IV) infusion of Crenezumab every 4 weeks (Q4W) for 100 weeks.
|
|
|
|
|
|
|
|
|
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
Participants received intravenous (IV) infusion of Crenezumab every 4 weeks (Q4W) for 100 weeks. |
|
|
|
|
|
|
Participants received intravenous (IV) infusion of Crenezumab every 4 weeks (Q4W) for 100 weeks. |
|
|
|
Participants received intravenous (IV) infusion of Crenezumab every 4 weeks (Q4W) for 100 weeks.
|
|
|
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
|
|
|
|
| Counts |
|---|
| Participants |
|
|
|
| Counts |
|---|
| Participants |
|
|
|
| Counts |
|---|
| Participants |
|
|
|