Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2016-002976-28 | EudraCT Number |
Not provided
Not provided
The study was terminated due to safety issues.
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Amgen | INDUSTRY |
| Banner Alzheimer's Institute | OTHER |
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to determine the effects of CNP520 on cognition, global clinical status, and underlying AD pathology, as well as the safety of CNP520, in people at risk for the onset of clinical symptoms of AD based on their age, APOE genotype and elevated amyloid.
This trial was a randomized, double-blind, placebo-controlled, parallel group, adaptive design with variable treatment duration planned in cognitively unimpaired participants aged 60 to 75 years, with at least one apolipoprotein E allele (APOE4), (homozygotes (HMs) or heterozygotes (HTs)) and, if HTs, with evidence of elevated brain amyloid. The participants were randomized to either CNP520 50 mg, CNP520 15 mg or placebo a 2:1:2 ratio and was stratified based on amyloid status. The planned treatment period of 5 to 8 years was not achieved due to early study termination.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CNP520 50 mg | Experimental | 50 mg capsule taken orally once daily |
|
| CNP520 15 mg | Experimental | 15 mg capsule taken orally once daily |
|
| Placebo | Placebo Comparator | Matching placebo to 15 and 50 mg CNP520 taken orally once daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CNP520 50mg | Drug | 50 mg capsule |
| |
| CNP520 15mg |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Event (Diagnosis of Mild Cognitive Impairment or Dementia, Due to Alzheimer's Disease (AD)) | Event was defined as the first confirmed diagnosis of MCI due to Alzheimer's disease (AD) or dementia due to AD (whichever occurred first) after adjudication by the progression adjudication committee (PAC) as triggered either by an investigator diagnosis or an increase in the Clinical Dementia Rating (CDR) global score. An event had to be confirmed by the PAC at two consecutive visits. In case no confirmed event was observed for a participant, the observation was censored, and the censoring date was defined as the last date where the diagnostic classification was assessed. The Study was terminated and only confirmed events collected up to the data cut-off point were counted. Due to the early termination of the study only a small number of events were observed and time-to-event could not be analyzed. Kaplan-Meyer (KM) estimates were provided to estimate probability that a subject would have an event prior to the specified visit. | Baseline to last cognitive assessment performed (up to day 648) |
| Change in the Alzheimer's Prevention Initiative Composite Cognitive (APCC) Test Score | APCC is a composite score derived from the specific scores from the Repeatable Battery for the Assessment of Neurological Status (RBANS), Mini-Mental State Examination (MMSE) and the Raven's Progressive Matrices. The APCC score is a weighted score with ranges from from 0 to 100 where higher scores correspond to better cognitive performance. | Baseline to Week 26, Baseline to Last on-treatment (Day 547) and Baseline to Last off-treatment (Day 648) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Clinical Dementia Rating Scale Sum of Boxes (CDR-SOB) Score | The CDR was obtained through semi-structured interviews of participants and informants, and cognitive functioning was rated on a 5-point scale of functioning in six domains: memory, orientation, judgement and problem solving, community affairs, home and hobbies, and personal care. The CDR global score ranged from zero to three, while the CDR-SOB was the sum of the ratings from the six domains, ranging from 0 to 18 with a minimum increment of 0.5. Higher scores indicated greater disease severity |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Banner Alzheimer's Institute, 901 East Willetta Street | Phoenix | Arizona | 85006 | United States | ||
| Banner Sun Health Research Institute, 10515 West Santa Fe Drive, Building B |
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.
This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
Not provided
Not provided
Not provided
Not provided
8970 participants were screened
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | CNP520 50 mg | 50 mg capsule taken orally once daily |
| FG001 | CNP520 15 mg | 15 mg capsule taken orally once daily |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 7, 2020 | Mar 25, 2021 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Drug |
15 mg capsule |
|
| Matching placebo | Other | Matching placebo for 15 and 50 mg capsules |
|
| Baseline to Week 26, Baseline to Last on-treatment (Day 547) and Baseline to Last off-treatment (Day 648) |
| Change in the Total and Index Scores of the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) | Repeatable Battery for the Assessment of Neurological Status (RBANS) is a clinical tool designed to detect and characterize the earliest neurocognitive changes associated with dementia. The RBANS generates age-adjusted index scores for five neurocognitive domains: Immediate Memory, Visuospatial/Constructional, Language, Attention and Delayed Memory, which are used to calculate a Total Scale Index score. Index scores and total score range from 40 to 160 and a higher score indicates better cognitive functioning. | Baseline to Week 26, Baseline to Last on-treatment (Day 547) and Baseline to Last off-treatment (Day 648) |
| Change in the Everyday Cognition Scale (ECog-Subject) Total Scores | Everyday Cognition Scale (ECog) measures cognitively-relevant everyday abilities comprised of 39 items covering 6 cognitively-relevant domains: Everyday Memory, Everyday Language, Everyday Visuospatial Abilities, Everyday Planning, Everyday Organization, and Everyday Divided Attention. The questionnaire is a self-reported measure completed by both participant and study partner (informant). The total score for the 39 items ranges from 39 to 195, with greater scores indicating worse daily function. | Baseline to Week 26, Baseline to Last on-treatment (Day 547) and Baseline to Last off-treatment (Day 648) |
| Change in the Everyday Cognition Scale (ECog-Informant) Total Scores | Everyday Cognition Scale (ECog) measures cognitively-relevant everyday abilities comprised of 39 items covering 6 cognitively-relevant domains: Everyday Memory, Everyday Language, Everyday Visuospatial Abilities, Everyday Planning, Everyday Organization, and Everyday Divided Attention. The questionnaire is a self-reported measure completed by both participant and study partner (informant). The total score for the 39 items ranges from 39 to 195, with greater scores indicating worse daily function. | Baseline to Week 26, Baseline to Last on-treatment (Day 547) and Baseline to Last off-treatment (Day 648) |
| Number of Participants With Newly Occurring Safety MRI Abnormalities (ARIA-E, ARIA-H,White Matter Disease and Any Other MRI Abnormalities) | Safety MRI included sequences necessary for ascertainment of possible ARIA-E (Amyloid Related Imaging Abnormality-Edema), ARIA-H (Amyloid Related Imaging Abnormality- Hemorrhage, including superficial siderosis and microhemorrhages), assessment of recent infarcts and white matter integrity examination (White matter disease worsening) and a general assessment of brain abnormalities. | Baseline up to study termination approximately 617 days |
| Annualized Percent Change on Volume of Brain Regions | Annualized % change from baseline in volume of specific brain regions of interest (ROIs): whole brain (WB), hippocampus (Hip), and lateral ventricles (LV). Annualized percentage change was calculated as (percentage per participant / time interval (in days)) x 365.25. Time interval (in days) was derived as date of current MRI assessment on study drug - date of baseline MRI assessment + 1. | Baseline to Week 26, Baseline to Last on-treatment (Day 547) and Baseline to Last off-treatment (Day 648) |
| Change in CSF Levels of Amyloid Beta 40 (Aβ40) | Alzheimer's Disease-related biomarkers analyzed in cerebrospinal fluid (CSF): Amyloid Beta 40 (Aβ40) | Baseline to Last on-treatment (Day 547) and Baseline to Last off-treatment (Day 648) |
| Change in CSF Levels of Amyloid Beta 42 (Aβ42) | Alzheimer's Disease-related biomarkers analyzed in cerebrospinal fluid (CSF): Amyloid Beta 42 (Aβ42). | Baseline to Last on-treatment (Day 547) and Baseline to Last off-treatment (Day 648) |
| Change in Neurofibrillary Tangle Burden as Measured by Standardized Uptake Ratio (SUVR) of PET Scans With Tau Radiotracer (Where Available) | To demonstrate the effects of CNP520 vs placebo on Alzheimer's Disease-related biomarkers | Baseline to Months 24 and 60 |
| Change in Amyloid Deposition as Measured by Standardized Uptake Ratio (SUVR) of Positron Emission Tomography (PET) Scan With Amyloid Radiotracer | To demonstrate the effects of CNP520 vs placebo on Alzheimer's Disease-related biomarkers | Baseline to Months 24 and 60 |
| Change in CSF Levels of Total Tau and Phosphorylated Tau | Alzheimer's Disease-related biomarkers analyzed in cerebrospinal fluid (CSF): total tau protein and phosphorylated tau protein levels | Baseline to Last on-treatment (Day 547) Baseline to Last off-treatment (Day 648) |
| Change in Serum Neurofilaments | Alzheimer's Disease-related biomarkers analyzed in blood serum: light chain neurofilaments (NfL) | Baseline to Week 26, baseline to Last on-treatment (Day 547) Baseline to Last off-treatment (Day 648) |
| Number of Suicidal Ideation or Behavior Events | Prospective suicidality assessment was performed with the use of Columbia-Suicide Severity Rating Scale (C-SSRS), a questionnaire using a detailed branched logic algorithm evaluating participant's suicidality ideation and behavior. Answer "yes" on item 4 or 5 of the Suicidal Ideation section or "yes" on any item of the Suicidal Behavior section was considered positive. | Baseline up to study termination approximately 617 days |
| Sun City |
| Arizona |
| 85351 |
| United States |
| Novartis Investigative Site | Tucson | Arizona | 85724 | United States |
| ATP Clinical Research Inc, 3151 Airway Avenue T 3 | Costa Mesa | California | 92626 | United States |
| Irvine Center for Clinical Res, 2515 McCabe Way | Irvine | California | 92618 | United States |
| Torrance Clinical Research Institute, 25043 Narbonne Avenue | Lomita | California | 90717 | United States |
| Novartis Investigative Site | Oxnard | California | 93030 | United States |
| Novartis Investigative Site | Palo Alto | California | 94304 | United States |
| Novartis Investigative Site | San Diego | California | 92103 | United States |
| Syrentis Clinical Research, 1401 N Tustin Ave, Suite 130 | Santa Ana | California | 92705 | United States |
| Novartis Investigative Site | Sebastopol | California | 95472 | United States |
| Novartis Investigative Site | Sherman Oaks | California | 91403 | United States |
| Mountain Neurological Research, 350 Market Street, Suite 316 | Basalt | Colorado | 81621 | United States |
| Colorado Springs Neurological, 2312 North Nevada Avenue, Suite 100 | Colorado Springs | Colorado | 80907 | United States |
| Denver Neurological Clinic, 950 E Harvard Ave | Denver | Colorado | 80210 | United States |
| Yale University, One Church Street, Suite 600 | New Haven | Connecticut | 06519 | United States |
| Novartis Investigative Site | Stamford | Connecticut | 06905 | United States |
| Novartis Investigative Site | Washington D.C. | District of Columbia | 20057 | United States |
| Novartis Investigative Site | Atlantis | Florida | 33462-6608 | United States |
| Quantum Laboratories | Deerfield Beach | Florida | 33064 | United States |
| Brain Matters Research, Inc., 800 NW 17th Avenue | Delray Beach | Florida | 33445 | United States |
| Infinity Clinical Research LLC, 4925 Sheridan Street, Suite 200 | Hollywood | Florida | 33021 | United States |
| Alzheimer's Research and Treatment Center, 5065 State Road 7, Suite 102 | Lake Worth | Florida | 33449 | United States |
| Meridien Research, 2300 Maitland center, Pkwy Ste 230 | Maitland | Florida | 32751 | United States |
| Novartis Investigative Site | Melbourne | Florida | 32940 | United States |
| Novartis Investigative Site | Merritt Island | Florida | 32952 | United States |
| Novartis Investigative Site | Miami | Florida | 33032 | United States |
| Novartis Investigative Site | Miami | Florida | 33136 | United States |
| New Horizon Research Center, 11880 SW 40 St., Suite 405 | Miami | Florida | 33175 | United States |
| Miami-Dade Medical Research, 8955 SW 87 CT, Suite 112 | Miami | Florida | 33176 | United States |
| Novartis Investigative Site | Miami Beach | Florida | 33140 | United States |
| Compass Research, LLC,100 West Gore Street, Suite 202 | Orlando | Florida | 32806 | United States |
| Novartis Investigative Site | Orlando | Florida | 32806 | United States |
| Novartis Investigative Site | Ormond Beach | Florida | 32174 | United States |
| Novartis Investigative Site | Palm Beach Gardens | Florida | 33410 | United States |
| Novartis Investigative Site | Port Orange | Florida | 32127 | United States |
| Roskamp Institute, Inc., 2040 Whitfield Avenue | Sarasota | Florida | 34243 | United States |
| Novartis Investigative Site | Tallahassee | Florida | 32308 | United States |
| Novartis Investigative Site | Tampa | Florida | 33613 | United States |
| Novartis Investigative Site | West Palm Beach | Florida | 33407 | United States |
| Novartis Investigative Site | Atlanta | Georgia | 30322 | United States |
| Novartis Investigative Site | Columbus | Georgia | 31909 | United States |
| Novartis Investigative Site | Decatur | Georgia | 30033 | United States |
| Hawaii Pacific Neuroscience, 2230 Liliha st 104 | Honolulu | Hawaii | 96817 | United States |
| Advanced Clinical Research, 2950 E Magic View Dr, Suite 182 | Meridian | Idaho | 83642 | United States |
| Novartis Investigative Site | Chicago | Illinois | 60612 | United States |
| Novartis Investigative Site | Chicago | Illinois | 60640 | United States |
| Alexian Brothers Neuroscience, 800 Biesterfield Rd, Neuroscience Institute Brock | Elk Grove Village | Illinois | 60007 | United States |
| Novartis Investigative Site | Indianapolis | Indiana | 46202 | United States |
| Novartis Investigative Site | Fairway | Kansas | 66205 | United States |
| Novartis Investigative Site | Wichita | Kansas | 67206 | United States |
| Novartis Investigative Site | Wichita | Kansas | 67214 | United States |
| Novartis Investigative Site | Lexington | Kentucky | 40536-0284 | United States |
| Novartis Investigative Site | Bangor | Maine | 04401 | United States |
| Novartis Investigative Site | Boston | Massachusetts | 02118 | United States |
| Novartis Investigative Site | Boston | Massachusetts | 02215 | United States |
| QUEST Research Institute, 28595 Orchard Lake Road, Suite 301 | Farmington Hills | Michigan | 48334 | United States |
| Novartis Investigative Site | Kalamazoo | Michigan | 49008 | United States |
| Novartis Investigative Site | Rochester | Minnesota | 55905 | United States |
| Hattiesburg Clinic, 415 South 28th Avenue | Hattiesburg | Mississippi | 39401 | United States |
| Novartis Investigative Site | St Louis | Missouri | 63104 | United States |
| Novartis Investigative Site | Omaha | Nebraska | 68198 7680 | United States |
| Novartis Investigative Site | West Long Branch | New Jersey | 07764 | United States |
| Albuquerque Neuroscience, 101 Hospital Loop ne, 209 209 | Albuquerque | New Mexico | 87109 | United States |
| Novartis Investigative Site | Brooklyn | New York | 11235 | United States |
| Novartis Investigative Site | East Syracuse | New York | 13057 | United States |
| Novartis Investigative Site | Latham | New York | 12110 | United States |
| NYU Langone Medical Center, 145 East 32nd Street, 2nd Floor, Room 226 | New York | New York | 10016 | United States |
| Novartis Investigative Site | Orangeburg | New York | 10962 | United States |
| Novartis Investigative Site | Rochester | New York | 14642 | United States |
| ANI Neurology, PLLC dba Alzhe, 7809 Sardis Road | Charlotte | North Carolina | 28270 | United States |
| Novartis Investigative Site | Durham | North Carolina | 27710 | United States |
| Novartis Investigative Site | Greensboro | North Carolina | 27410 | United States |
| Novartis Investigative Site | Cincinnati | Ohio | 45242 | United States |
| Novartis Investigative Site | Oklahoma City | Oklahoma | 73112 | United States |
| Tulsa Clinical Research LLC, 1705 E 19th ST., STE 406/408 | Tulsa | Oklahoma | 74104 | United States |
| Summit Research Network, 2701 NW Vaughn St, Suite 350 | Portland | Oregon | 97210 | United States |
| Novartis Investigative Site | Portland | Oregon | 97239 | United States |
| Novartis Investigative Site | Jenkintown | Pennsylvania | 19046 | United States |
| Novartis Investigative Site | Philadelphia | Pennsylvania | 19104 | United States |
| Abington Neurological Associate Ltd., 2325 Maryland Road, Suite 100 | Willow Grove | Pennsylvania | 19090 | United States |
| Rhode Island Hospital and Memory Research Institute, 1018 Waterman Ave | East Providence | Rhode Island | 02914 | United States |
| Butler Hospital, 345 Blackstone Blvd. | Providence | Rhode Island | 02906 | United States |
| Roper Hospital, 316 Calhoun Street 5th Floor | Charleston | South Carolina | 29401 | United States |
| Novartis Investigative Site | Knoxville | Tennessee | 37920 | United States |
| Novartis Investigative Site | Memphis | Tennessee | 38119 | United States |
| Novartis Investigative Site | Nashville | Tennessee | 37212 | United States |
| Novartis Investigative Site | Austin | Texas | 78757 | United States |
| Novartis Investigative Site | Dallas | Texas | 75231 | United States |
| Novartis Investigative Site | Houston | Texas | 77030 | United States |
| Novartis Investigative Site | Houston | Texas | 77054 | United States |
| Novartis Investigative Site | San Antonio | Texas | 78229 | United States |
| Novartis Investigative Site | Bennington | Vermont | 05201 | United States |
| Novartis Investigative Site | Tacoma | Washington | 98405 | United States |
| Novartis Investigative Site | Milwaukee | Wisconsin | 53226 | United States |
| Novartis Investigative Site | CABA | Buenos Aires | C1428AQK | Argentina |
| Novartis Investigative Site | Buenos Aires | C1012AAR | Argentina |
| Novartis Investigative Site | Darlinghurst | New South Wales | 2010 | Australia |
| Novartis Investigative Site | Heidelberg West | Victoria | 3081 | Australia |
| Novartis Investigative Site | Nedlands | Western Australia | 6009 | Australia |
| Novartis Investigative Site | Ghent | 9000 | Belgium |
| Novartis Investigative Site | Leuven | 3000 | Belgium |
| Novartis Investigative Site | Kelowna | British Columbia | V1Y1Z9 | Canada |
| Novartis Investigative Site | Kentville | Nova Scota | B4N 4K9 | Canada |
| Novartis Investigative Site | Halifax | Nova Scotia | B3S 1M7 | Canada |
| Novartis Investigative Site | Ottawa | Ontario | K1G 1Z3 | Canada |
| Toronto Memory Program, 1 Valleybrook Drive Suite 400 | Toronto | Ontario | M3B 2S7 | Canada |
| Novartis Investigative Site | Toronto | Ontario | M4G 3E8 | Canada |
| Novartis Investigative Site | Toronto | Ontario | M4N 3M5 | Canada |
| Novartis Investigative Site | Gatineau | Quebec | J8T 8J1 | Canada |
| Novartis Investigative Site | Greenfield Park | Quebec | J4V 2J2 | Canada |
| Novartis Investigative Site | Québec | Quebec | G1J 1Z4 | Canada |
| Novartis Investigative Site | Santiago | 7500710 | Chile |
| Novartis Investigative Site | Santiago | 838 0456 | Chile |
| Novartis Investigative Site | Shanghai | Shanghai Municipality | 200080 | China |
| Novartis Investigative Site | Beijing | 100053 | China |
| Novartis Investigative Site | Guangdong | 510370 | China |
| Novartis Investigative Site | Kuopio | 70210 | Finland |
| Novartis Investigative Site | Turku | 20520 | Finland |
| Novartis Investigative Site | Strasbourg | Cedex | 67098 | France |
| Novartis Investigative Site | Lille | 59037 | France |
| Novartis Investigative Site | Paris | 75651 | France |
| Novartis Investigative Site | Rouen | 76031 | France |
| Novartis Investigative Site | Toulouse | 31059 | France |
| Novartis Investigative Site | Villeurbanne | 69100 | France |
| Novartis Investigative Site | Bayreuth | 95445 | Germany |
| Novartis Investigative Site | Berlin | 13353 | Germany |
| Novartis Investigative Site | Cologne | 50937 | Germany |
| Novartis Investigative Site | Leipzig | 04107 | Germany |
| Novartis Investigative Site | Mannheim | 68159 | Germany |
| Novartis Investigative Site | Siegen | 57076 | Germany |
| Novartis Investigative Site | Kopavogur | IS-201 | Iceland |
| Novartis Investigative Site | Ashkelon | 78278 | Israel |
| Novartis Investigative Site | Haifa | 31096 | Israel |
| Novartis Investigative Site | Petah Tikva | 49100 | Israel |
| Novartis Investigative Site | Ramat Gan | 52621 | Israel |
| Novartis Investigative Site | Tel Aviv | 6423906 | Israel |
| Novartis Investigative Site | Brescia | BS | 25100 | Italy |
| Novartis Investigative Site | Rome | Lazio | 00168 | Italy |
| Novartis Investigative Site | Monza | MB | 20900 | Italy |
| Novartis Investigative Site | Milan | 20112 | Italy |
| Novartis Investigative Site | Tōon | Ehime | 791-0295 | Japan |
| Novartis Investigative Site | Fukuoka | Fukuoka | 814 0180 | Japan |
| Novartis Investigative Site | Yokohama | Kanagawa | 236-0004 | Japan |
| Novartis Investigative Site | Suita | Osaka | 565 0871 | Japan |
| Novartis Investigative Site | Bunkyo Ku | Tokyo | 113 8655 | Japan |
| Novartis Investigative Site | Bunkyo Ku | Tokyo | 113-8431 | Japan |
| Novartis Investigative Site | Kodaira | Tokyo | 187-8551 | Japan |
| Novartis Investigative Site | Shinjuku-ku | Tokyo | 160 8582 | Japan |
| Novartis Investigative Site | Chiba | 260 8677 | Japan |
| Novartis Investigative Site | Osaka | 545-8586 | Japan |
| Novartis Investigative Site | Mexico City | Mexico CP | 14080 | Mexico |
| Novartis Investigative Site | Monterrey | Nuevo León | 64710 | Mexico |
| Novartis Investigative Site | Culiacán | Sinaloa | 80020 | Mexico |
| Novartis Investigative Site | 's-Hertogenbosch | North Brabant | 5223 LA | Netherlands |
| Novartis Investigative Site | Amsterdam | 1081 GN | Netherlands |
| Novartis Investigative Site | Torres Vedras | Lisbon District | 2560-280 | Portugal |
| Novartis Investigative Site | Coimbra | 3000 075 | Portugal |
| Novartis Investigative Site | Lisbon | 1998-018 | Portugal |
| Novartis Investigative Site | Matosinhos Municipality | 4454 513 | Portugal |
| Inspira Clinical Research, Ave Hostos 405 | San Juan | 00918 | Puerto Rico |
| Novartis Investigative Site | Singapore | 308433 | Singapore |
| Novartis Investigative Site | Rosebank | Johannesburg | 2132 | South Africa |
| Novartis Investigative Site | Cape Town | Western Cape | 7530 | South Africa |
| Novartis Investigative Site | George | ZAF | 6529 | South Africa |
| Novartis Investigative Site | Suwon | Gyeonggi-do | 16499 | South Korea |
| Novartis Investigative Site | Busan | 49201 | South Korea |
| Novartis Investigative Site | Incheon | 22332 | South Korea |
| Novartis Investigative Site | Seoul | 05505 | South Korea |
| Novartis Investigative Site | Seoul | 06351 | South Korea |
| Novartis Investigative Site | Terrassa | Barcelona | 08221 | Spain |
| Novartis Investigative Site | Pozuelo de Alarcón | Madrid | 28223 | Spain |
| Novartis Investigative Site | Barcelona | 08005 | Spain |
| Novartis Investigative Site | Barcelona | 08014 | Spain |
| Novartis Investigative Site | Donostia / San Sebastian | 20009 | Spain |
| Novartis Investigative Site | Madrid | 28034 | Spain |
| Novartis Investigative Site | Madrid | 28041 | Spain |
| Novartis Investigative Site | Basel | CH | 4002 | Switzerland |
| Novartis Investigative Site | Geneva | 1227 | Switzerland |
| Novartis Investigative Site | Lausanne | CH-1011 | Switzerland |
| Novartis Investigative Site | Kaoshiung | 83301 | Taiwan |
| Novartis Investigative Site | New Taipei City | 23561 | Taiwan |
| Novartis Investigative Site | Taipei | 11217 | Taiwan |
| Novartis Investigative Site | Exeter | Devon | EX2 5DW | United Kingdom |
| Novartis Investigative Site | Plymouth | Devon | PL6 8BT | United Kingdom |
| Novartis Investigative Site | London | GBR | W12 7RH | United Kingdom |
| Novartis Investigative Site | Guildford | Surrey | GU27YD | United Kingdom |
| Novartis Investigative Site | Avon | BA1 3NG | United Kingdom |
| Novartis Investigative Site | Birmingham | B16 8QQ | United Kingdom |
| Novartis Investigative Site | Bristol | BS10 5NB | United Kingdom |
| Novartis Investigative Site | Dundee | DD1 9SY | United Kingdom |
| Novartis Investigative Site | Glasgow | United Kingdom |
| Novartis Investigative Site | London | W12 0HS | United Kingdom |
| Novartis Investigative Site | London | W1G 9JF | United Kingdom |
| FG002 |
| Placebo |
Matching placebo to 15 and 50 mg CNP520 taken orally once daily |
| Patient Misrandomized |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
One patient was misrandomized and not included in the CNP520 50mg arm
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | CNP520 50 mg | 50 mg capsule taken orally once daily |
| BG001 | CNP520 15 mg | 15 mg capsule taken orally once daily |
| BG002 | Placebo | Matching placebo to 15 and 50 mg CNP520 taken orally once daily |
| BG003 | 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, Customized | Number | participants |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Number | participants |
| ||||||||||||||||
| Baseline cognitive scale assessment | APCC(API Preclinical Composite Cognitive Battery) is a composite score derived from RBANS(Repeatable Battery for Assessment of Neurological Status), MMSE(Mini-Mental State Examination) and the Raven's Progressive Matrices; scores: 0-100/higher scores=better cognitive performance. RBANS is a tool to detect/characterize neurocognitive dementia changes in 5 neurocognitive domains; scores: 40-160/higher scores=better cognitive functioning. Clinical Dementia Rating Sum of Boxes(CDR-SOB) measures cognition+functioning in 6 domains; scores: 0-18/higher scores indicate greater disease severity | Mean | Standard Deviation | scores on a scale |
|
| 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 | Time to Event (Diagnosis of Mild Cognitive Impairment or Dementia, Due to Alzheimer's Disease (AD)) | Event was defined as the first confirmed diagnosis of MCI due to Alzheimer's disease (AD) or dementia due to AD (whichever occurred first) after adjudication by the progression adjudication committee (PAC) as triggered either by an investigator diagnosis or an increase in the Clinical Dementia Rating (CDR) global score. An event had to be confirmed by the PAC at two consecutive visits. In case no confirmed event was observed for a participant, the observation was censored, and the censoring date was defined as the last date where the diagnostic classification was assessed. The Study was terminated and only confirmed events collected up to the data cut-off point were counted. Due to the early termination of the study only a small number of events were observed and time-to-event could not be analyzed. Kaplan-Meyer (KM) estimates were provided to estimate probability that a subject would have an event prior to the specified visit. | Safety analysis set; n=number of participants at risk to experience an event at the time-point | Posted | Number | 95% Confidence Interval | probability of an event | Baseline to last cognitive assessment performed (up to day 648) |
|
|
| |||||||||||||||||||||||||||||||
| Primary | Change in the Alzheimer's Prevention Initiative Composite Cognitive (APCC) Test Score | APCC is a composite score derived from the specific scores from the Repeatable Battery for the Assessment of Neurological Status (RBANS), Mini-Mental State Examination (MMSE) and the Raven's Progressive Matrices. The APCC score is a weighted score with ranges from from 0 to 100 where higher scores correspond to better cognitive performance. | Safety analysis set - only participants with a value at both Baseline and that visit are included. Last on-treatment is the last assessment before or at last day on study drug + 31 days. Last off-treatment is the last assessment after last day on study drug + 31 days. | Posted | Mean | Standard Deviation | Total scores | Baseline to Week 26, Baseline to Last on-treatment (Day 547) and Baseline to Last off-treatment (Day 648) |
| |||||||||||||||||||||||||||||||||
| Secondary | Change in Clinical Dementia Rating Scale Sum of Boxes (CDR-SOB) Score | The CDR was obtained through semi-structured interviews of participants and informants, and cognitive functioning was rated on a 5-point scale of functioning in six domains: memory, orientation, judgement and problem solving, community affairs, home and hobbies, and personal care. The CDR global score ranged from zero to three, while the CDR-SOB was the sum of the ratings from the six domains, ranging from 0 to 18 with a minimum increment of 0.5. Higher scores indicated greater disease severity | Safety analysis set - only participants with a value at both Baseline and that visit are included. Last on-treatment is the last assessment before or at last day on study drug + 31 days. Last off-treatment is the last assessment after last day on study drug + 31 days. | Posted | Mean | Standard Deviation | Scores on a scale | Baseline to Week 26, Baseline to Last on-treatment (Day 547) and Baseline to Last off-treatment (Day 648) |
| |||||||||||||||||||||||||||||||||
| Secondary | Change in the Total and Index Scores of the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) | Repeatable Battery for the Assessment of Neurological Status (RBANS) is a clinical tool designed to detect and characterize the earliest neurocognitive changes associated with dementia. The RBANS generates age-adjusted index scores for five neurocognitive domains: Immediate Memory, Visuospatial/Constructional, Language, Attention and Delayed Memory, which are used to calculate a Total Scale Index score. Index scores and total score range from 40 to 160 and a higher score indicates better cognitive functioning. | Safety analysis set - only participants with a value at both Baseline and that visit are included. Last on-treatment is the last assessment before or at last day on study drug + 31 days. Last off-treatment is the last assessment after last day on study drug + 31 days. | Posted | Mean | Standard Deviation | scores | Baseline to Week 26, Baseline to Last on-treatment (Day 547) and Baseline to Last off-treatment (Day 648) |
| |||||||||||||||||||||||||||||||||
| Secondary | Change in the Everyday Cognition Scale (ECog-Subject) Total Scores | Everyday Cognition Scale (ECog) measures cognitively-relevant everyday abilities comprised of 39 items covering 6 cognitively-relevant domains: Everyday Memory, Everyday Language, Everyday Visuospatial Abilities, Everyday Planning, Everyday Organization, and Everyday Divided Attention. The questionnaire is a self-reported measure completed by both participant and study partner (informant). The total score for the 39 items ranges from 39 to 195, with greater scores indicating worse daily function. | Safety analysis set - only participants with a value at both Baseline and that visit are included. Last on-treatment is the last assessment before or at last day on study drug + 31 days. Last off-treatment is the last assessment after last day on study drug + 31 days. | Posted | Mean | Standard Deviation | Total scores | Baseline to Week 26, Baseline to Last on-treatment (Day 547) and Baseline to Last off-treatment (Day 648) |
| |||||||||||||||||||||||||||||||||
| Secondary | Change in the Everyday Cognition Scale (ECog-Informant) Total Scores | Everyday Cognition Scale (ECog) measures cognitively-relevant everyday abilities comprised of 39 items covering 6 cognitively-relevant domains: Everyday Memory, Everyday Language, Everyday Visuospatial Abilities, Everyday Planning, Everyday Organization, and Everyday Divided Attention. The questionnaire is a self-reported measure completed by both participant and study partner (informant). The total score for the 39 items ranges from 39 to 195, with greater scores indicating worse daily function. | Safety analysis set - only participants with a value at both Baseline and that visit are included. Last on-treatment is the last assessment before or at last day on study drug + 31 days. Last off-treatment is the last assessment after last day on study drug + 31 days. | Posted | Mean | Standard Deviation | Total scores | Baseline to Week 26, Baseline to Last on-treatment (Day 547) and Baseline to Last off-treatment (Day 648) |
| |||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Newly Occurring Safety MRI Abnormalities (ARIA-E, ARIA-H,White Matter Disease and Any Other MRI Abnormalities) | Safety MRI included sequences necessary for ascertainment of possible ARIA-E (Amyloid Related Imaging Abnormality-Edema), ARIA-H (Amyloid Related Imaging Abnormality- Hemorrhage, including superficial siderosis and microhemorrhages), assessment of recent infarcts and white matter integrity examination (White matter disease worsening) and a general assessment of brain abnormalities. | Safety analysis set - only participants with a value at both Baseline and that visit are included. Last on-treatment is the last assessment before or at last day on study drug + 31 days. Last off-treatment is the last assessment after last day on study drug + 31 days. | Posted | Count of Participants | Participants | Baseline up to study termination approximately 617 days |
| ||||||||||||||||||||||||||||||||||
| Secondary | Annualized Percent Change on Volume of Brain Regions | Annualized % change from baseline in volume of specific brain regions of interest (ROIs): whole brain (WB), hippocampus (Hip), and lateral ventricles (LV). Annualized percentage change was calculated as (percentage per participant / time interval (in days)) x 365.25. Time interval (in days) was derived as date of current MRI assessment on study drug - date of baseline MRI assessment + 1. | Safety analysis set - only participants with a value at both Baseline and that visit are included. Last on-treatment is the last assessment before or at last day on study drug + 31 days. Last off-treatment is the last assessment after last day on study drug + 31 days. | Posted | Mean | Standard Deviation | Percentage of volume change | Baseline to Week 26, Baseline to Last on-treatment (Day 547) and Baseline to Last off-treatment (Day 648) |
| |||||||||||||||||||||||||||||||||
| Secondary | Change in CSF Levels of Amyloid Beta 40 (Aβ40) | Alzheimer's Disease-related biomarkers analyzed in cerebrospinal fluid (CSF): Amyloid Beta 40 (Aβ40) | Safety analysis set - only participants with a value at both Baseline and that visit are included. Last on-treatment is the last assessment before or at last day on study drug + 31 days. Last off-treatment is the last assessment after last day on study drug + 31 days. | Posted | Mean | Standard Deviation | ng/mL | Baseline to Last on-treatment (Day 547) and Baseline to Last off-treatment (Day 648) |
|
| ||||||||||||||||||||||||||||||||
| Secondary | Change in CSF Levels of Amyloid Beta 42 (Aβ42) | Alzheimer's Disease-related biomarkers analyzed in cerebrospinal fluid (CSF): Amyloid Beta 42 (Aβ42). | Safety analysis set - only participants with a value at both Baseline and that visit are included. Last on-treatment is the last assessment before or at last day on study drug + 31 days. Last off-treatment is the last assessment after last day on study drug + 31 days. | Posted | Mean | Standard Deviation | pg/mL | Baseline to Last on-treatment (Day 547) and Baseline to Last off-treatment (Day 648) |
|
| ||||||||||||||||||||||||||||||||
| Secondary | Change in Neurofibrillary Tangle Burden as Measured by Standardized Uptake Ratio (SUVR) of PET Scans With Tau Radiotracer (Where Available) | To demonstrate the effects of CNP520 vs placebo on Alzheimer's Disease-related biomarkers | No available data since no post-baseline (month 24 and 60) PET scan could be obtained due to the early termination of the trial. | Posted | Baseline to Months 24 and 60 |
|
| |||||||||||||||||||||||||||||||||||
| Secondary | Change in Amyloid Deposition as Measured by Standardized Uptake Ratio (SUVR) of Positron Emission Tomography (PET) Scan With Amyloid Radiotracer | To demonstrate the effects of CNP520 vs placebo on Alzheimer's Disease-related biomarkers | No available data since no post-baseline (month 24 and 60) PET scan could be obtained due to the early termination of the trial. | Posted | Baseline to Months 24 and 60 |
|
| |||||||||||||||||||||||||||||||||||
| Secondary | Change in CSF Levels of Total Tau and Phosphorylated Tau | Alzheimer's Disease-related biomarkers analyzed in cerebrospinal fluid (CSF): total tau protein and phosphorylated tau protein levels | Safety analysis set - only participants with a value at both Baseline and that visit are included. Last on-treatment is the last assessment before or at last day on study drug + 31 days. Last off-treatment is the last assessment after last day on study drug + 31 days. | Posted | Mean | Standard Deviation | pg/mL | Baseline to Last on-treatment (Day 547) Baseline to Last off-treatment (Day 648) |
|
| ||||||||||||||||||||||||||||||||
| Secondary | Change in Serum Neurofilaments | Alzheimer's Disease-related biomarkers analyzed in blood serum: light chain neurofilaments (NfL) | Safety analysis set - only participants with a value at both Baseline and that visit are included. Last on-treatment is the last assessment before or at last day on study drug + 31 days. Last off-treatment is the last assessment after last day on study drug + 31 days. | Posted | Mean | Standard Deviation | pg/mL | Baseline to Week 26, baseline to Last on-treatment (Day 547) Baseline to Last off-treatment (Day 648) |
|
| ||||||||||||||||||||||||||||||||
| Secondary | Number of Suicidal Ideation or Behavior Events | Prospective suicidality assessment was performed with the use of Columbia-Suicide Severity Rating Scale (C-SSRS), a questionnaire using a detailed branched logic algorithm evaluating participant's suicidality ideation and behavior. Answer "yes" on item 4 or 5 of the Suicidal Ideation section or "yes" on any item of the Suicidal Behavior section was considered positive. | Safety analysis set which includes only participants with events | Posted | Number | events | Baseline up to study termination approximately 617 days |
|
|
Adverse events were reported from first dose of study treatment until end of study treatment plus 31 days of washout period for a maximum duration of 617 days.
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 | CNP520 50 mg | 50 mg capsule taken orally once daily | 0 | 455 | 15 | 455 | 137 | 455 |
| EG001 | CNP520 15 mg | 15 mg capsule taken orally once daily | 0 | 233 | 9 | 233 | 62 | 233 |
| EG002 | Placebo | Matching placebo to 15 and 50 mg CNP520 taken orally once daily | 0 | 456 | 15 | 456 | 89 | 456 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Aortic valve incompetence | Cardiac disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Coronary artery disease | Cardiac disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Mitral valve incompetence | Cardiac disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Supraventricular tachycardia | Cardiac disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Colitis ulcerative | Gastrointestinal disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Drug-induced liver injury | Hepatobiliary disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Hepatic cirrhosis | Hepatobiliary disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (23.0) | Systematic Assessment |
| |
| Pneumonia influenzal | Infections and infestations | MedDRA (23.0) | Systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | MedDRA (23.0) | Systematic Assessment |
| |
| Fibula fracture | Injury, poisoning and procedural complications | MedDRA (23.0) | Systematic Assessment |
| |
| Radius fracture | Injury, poisoning and procedural complications | MedDRA (23.0) | Systematic Assessment |
| |
| Subdural haematoma | Injury, poisoning and procedural complications | MedDRA (23.0) | Systematic Assessment |
| |
| Traumatic lung injury | Injury, poisoning and procedural complications | MedDRA (23.0) | Systematic Assessment |
| |
| Haemoglobin decreased | Investigations | MedDRA (23.0) | Systematic Assessment |
| |
| Hepatic enzyme increased | Investigations | MedDRA (23.0) | Systematic Assessment |
| |
| Serum ferritin decreased | Investigations | MedDRA (23.0) | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (23.0) | Systematic Assessment |
| |
| Bladder transitional cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (23.0) | Systematic Assessment |
| |
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (23.0) | Systematic Assessment |
| |
| Chordoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (23.0) | Systematic Assessment |
| |
| Endometrial cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (23.0) | Systematic Assessment |
| |
| Intraductal proliferative breast lesion | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (23.0) | Systematic Assessment |
| |
| Malignant melanoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (23.0) | Systematic Assessment |
| |
| Squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (23.0) | Systematic Assessment |
| |
| Squamous cell carcinoma of skin | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (23.0) | Systematic Assessment |
| |
| Cerebellar infarction | Nervous system disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Generalised tonic-clonic seizure | Nervous system disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Ischaemic stroke | Nervous system disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Parkinson's disease | Nervous system disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Seizure | Nervous system disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Major depression | Psychiatric disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Mania | Psychiatric disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Suicidal ideation | Psychiatric disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Aortic aneurysm | Vascular disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (23.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bronchitis | Infections and infestations | MedDRA (23.0) | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (23.0) | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (23.0) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (23.0) | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA (23.0) | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA (23.0) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Abnormal dreams | Psychiatric disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (23.0) | Systematic Assessment |
|
The study was terminated due to safety issues.
The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Novartis Pharmaceuticals | + 1 862 778 8300 | Novartis.email@Novartis.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 11, 2021 | Mar 25, 2021 | SAP_001.pdf |
Not provided
| 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 |
|---|---|
| C000628578 | Umibecestat |
Not provided
Not provided
Not provided
| 65-69 |
|
| >70 |
|
| Male |
|
| Black |
|
| Asian |
|
| Native American |
|
| Pacific Islander |
|
| Other |
|
| Unknown |
|
| RBANS Total |
|
| CDR-SOB |
|
| Week 52 n=52,24,57 |
|
|
| Week 78 n=6,2,2 |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
|
Matching placebo to 15 and 50 mg CNP520 taken orally once daily
|
|
|
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
|
|
|
|
|
|