Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2023-509807-34-00 | Registry Identifier | EU CT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The primary purpose of this study is to evaluate the efficacy of sabirnetug infusions administered once every four weeks (Q4W) in slowing cognitive and functional decline as compared to placebo in participants with early Alzheimer's disease.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Double-blind Treatment (DBT) Period: sabirnetug 35 mg/kg | Experimental | Participants will receive sabirnetug, 35 milligrams per kilogram (mg/kg), Q4W as intravenous (IV) infusion during the DBT period. |
|
| DBT Period: sabirnetug 50 mg/kg | Experimental | Participants will receive sabirnetug, 35 mg/kg, for the first two doses, followed by sabirnetug, 50 mg/kg, Q4W as an IV infusion during the DBT period. |
|
| DBT Period: Placebo | Placebo Comparator | Participants will receive sabirnetug matching placebo, Q4W as an IV infusion during the DBT period. |
|
| Open-Label Extension (OLE) Period: sabirnetug 35 mg/kg | Experimental | Participants will receive sabirnetug, 35 mg/kg, Q4W as an IV infusion during the OLE period. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| sabirnetug | Drug | Intravenous sabirnetug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in Integrated Alzheimer's Disease Rating Scale (iADRS) Score | iADRS is a validated composite of cognition and function made up of Alzheimer's Disease Assessment Scale - Cognitive Subscale 13-item (ADAS-Cog13) and the Alzheimer's Disease Cooperative Study - instrumental Activities of Daily Living scale (ADCS-iADL). ADAS-Cog13 is a rater-administered instrument consisting of 13 items assessing cognitive function areas most typically impaired in AD. ADAS-Cog13 scores range from 0 to 85, with higher scores indicating a greater deficit of global cognition. The ADCS-iADL is a subset of the 23-item ADCS-ADL (items 6a and 7 to 23). The iADLs are more complex skills required to successfully live independently. iADL-items score ranges from 0 to 59 (lower scores indicating greater impairment). The iADRS is calculated as a linear combination of total scores from the ADAS-Cog13 and ADCS-iADL. The iADRS score ranges from 0 to 144 with lower scores indicating worse performance. | Baseline up to Week 80 |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in ADCS-iADL Score | The ADCS-ADL is a 23-item inventory developed as a rater-administered questionnaire to be answered by a participant's study partner, where a participant's performance level is rated over the last 4 weeks, based on a set of performance descriptions. The ADCS-iADL is a subset of the 23-item ADCS-ADL (items 6a and 7 to 23). The iADLs are more complex skills required to successfully live independently, and include shopping, keeping appointments, traveling outside of the home, making a meal or snack, and reading and writing. The iADL-items score ranges from 0 to 59 with lower scores indicating greater impairment. |
Not provided
Inclusion Criteria:
Body weight of at least 30 kilograms (kg) (66 pounds [lbs]) and no more than 160 kg (352 lbs) at Screening
Must consent to apolipoprotein E4 (APOE4) genotype status assessment
Must meet all of the following criteria
If using cholinesterase inhibitors or memantine to treat symptoms related to AD, doses must be stable for at least three months (12 weeks) prior to Baseline and every attempt should be made to keep them at stable doses throughout the study
Must have a reliable informant or study partner who is willing and able to perform all the roles as specified in the study partner Informed Consent Form (ICF)
Female participants must be surgically sterile or be at least one-year post-menopausal. Male participants with a female partner of child-bearing potential must use adequate contraception
Exclusion Criteria:
Has any contraindications for MRI studies, including claustrophobia, the presence of metal (ferromagnetic) implants, or a cardiac pacemaker that is not compatible with MRI
MRI of the brain that is inconsistent with MCI or AD or results showing greater than four ARIA-H, presence of any ARIA-E, or superficial siderosis
History of significant or unstable neurological disease, other than AD, which may affect cognition or ability to complete the study, such as other dementias, serious infection of the brain, significant head trauma, uncontrolled seizures, stroke, or Parkinson´s disease
Current serious or unstable clinically important illness that, in the judgment of the site investigator, is likely to affect cognitive assessment including visual and hearing impairment or affect the participant's safety or ability to complete the study
Malignant disease in the last five years except for resected cutaneous squamous cell carcinoma in situ, basal cell carcinoma, cervical carcinoma in situ, or in situ prostate cancer with a normal posttreatment prostate-specific antibody (PSA)
Geriatric Depression Scale-Short Form (GDS-SF) score >10 or current symptoms meeting Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V), criteria for major depressive disorder or any current primary psychiatric diagnosis other than AD if, in the judgment of the site investigator, the psychiatric disorder or symptom is likely to confound interpretation of drug effect, affect cognitive assessments, or affect the participant´s ability to complete the study
Suicide risk, as determined by meeting any of the following criteria:
Conditions that may affect cognitive assessments during the study
Alcohol use disorder and/or substance use disorder within the last five years
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Neurology Center of Southern California - Carlsbad | Carlsbad | California | 92011-4219 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39800458 | Derived | Siemers E, Feaster T, Sethuraman G, Sundell K, Skljarevski V, Cline EN, Zhang H, Jerecic J, Honig LS, Salloway S, Sperling R, Trame MN, Dodds MG, Johnson K. INTERCEPT-AD, a phase 1 study of intravenous sabirnetug in participants with mild cognitive impairment or mild dementia due to Alzheimer's disease. J Prev Alzheimers Dis. 2025 Jan;12(1):100005. doi: 10.1016/j.tjpad.2024.100005. Epub 2025 Jan 1. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo | Drug | Intravenous Placebo |
|
| Baseline up to Week 80 |
| Change from Baseline in ADAS-Cog13 Score | ADAS-Cog is a rater-administered instrument, designed to assess the severity of dysfunction in cognition, characteristic of persons with AD. The ADAS-Cog13, the cognitive subscale of the ADAS, consists of 13 items assessing cognitive function areas most typically impaired in AD: orientation, verbal memory, language, praxis, delayed free recall, and digit cancellation. The scores range from 0 to 85, with higher scores indicating a greater deficit of global cognition. | Baseline up to Week 80 |
| Change from Baseline in Clinical Dementia Rating - Sum of Boxes (CDR-SB) | The CDR is obtained through semi-structured interviews of individuals with AD and informants. The ratings are obtained in six domains: memory, orientation, judgment & problem-solving, community affairs, home & hobbies, and personal care. Each domain is rated on a five-point scale of functioning as follows: 0 = no impairment; 0.5 = questionable impairment; 1 = mild impairment; 2 = moderate impairment; and 3 = severe impairment. CDR-SB score is obtained by summing each of the domain scores, with scores ranging from 0 to 18. Higher scores reflect greater cognitive and functional impairment. | Baseline up to Week 80 |
| Change from Baseline in Mini-Mental State Examination (MMSE) | MMSE is a standard staging and assessment tool in AD, designed for grading the cognitive state of individuals with AD. The scale comprises tasks concerning orientation, memory, attention, language, and praxis to evaluate an individual's cognitive state. MMSE total score ranges from 0 to 30, with lower scores indicative of greater cognitive impairment. | Baseline up to Week 80 |
| Change from Baseline in Quality of Life in Alzheimer's Disease (QoL-AD) | The QOL-AD tool is a 13-item assessment with each question scored on a 4-point scale where 1 = poor quality of life and 4 = excellent quality of life. Scores range from 13 to 52 with higher scores indicating better quality of life. | Baseline up to Week 80 |
| Change from Baseline in Neuropsychiatric Inventory Questionnaire (NPI-Q) Score | NPI-Q is a validated questionnaire completed by informants about participants for whom they care. Each of the 12 NPI-Q domains contains a survey question (answered in Yes/No) that reflects the cardinal symptoms of that domain. If the domain response is "Yes," the informant then rates the severity of the symptoms present within the last month on a 3-point scale and the distress of the symptom using a 5-point scale. The total NPI-Q severity score is the sum of the individual severity scores for each symptom and ranges from 0 to 36, with higher scores indicating more severe behavioral impairment. The total NPI-Q distress score is the sum of the individual distress scores for each symptom and ranges from 0 to 60, with higher scores indicating greater caregiver distress. | Baseline up to Week 80 |
| Change from Baseline in EuroQoL 5-Dimension 5-Level (EQ-5D-5L) | EQ-5D-5L is a self-report survey that measures quality of life. The EQ-5D-5L consists of an EQ-5D descriptive system and EQ visual analog scale (EQ VAS). The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has five levels, each assigned a unique 1-digit number: no problems, slight problems, moderate problems, severe problems, and extreme problems. The digits are combined into a 5-digit number that describes the participant's health state. The EQ VAS records the participant's health on a vertical visual analog scale, where the endpoints are labeled 0= the best health you can imagine, and 100= the worst health you can imagine. | Baseline up to Week 80 |
| Change from Baseline in Resource Utilization in Dementia (RUD) | The RUD questionnaire is a standardized tool and the most widely used instrument for resource use data collection in dementia, enabling comparison of costs of care across countries with differing health care provisions. It is designed to collect data on formal and informal care resource use and to be useful in different care settings, across different countries and care systems, and in both clinical studies and observational cost-of-illness studies. | Baseline up to Week 80 |
| Change from Baseline in Zarit Burden Interview (ZBI) | ZBI consists of 22 items. Twenty-one of the items are designed to measure several aspects of burden, whereas Item 22 is a global measure of burden. Response options for each item range from 0-4, and total scores range from 0-88, with higher scores indicating greater self-reported burden. | Baseline up to Week 80 |
| Effect of sabirnetug on Clinical Progression as Compared to Placebo Assessed Using Time Saved Analysis as Measured by iADRS | Baseline up to Week 80 |
| Effect of sabirnetug on Clinical Progression as Compared to Placebo Assessed Using Time Saved Analysis as Measured by ADCS-iADL | Baseline up to Week 80 |
| Effect of sabirnetug on Clinical Progression as Compared to Placebo Assessed Using Time Saved Analysis as Measured by ADAS-Cog13 | Baseline up to Week 80 |
| Effect of sabirnetug on Clinical Progression as Compared to Placebo Assessed Using Time Saved Analysis as Measured by CDR-SB | Baseline up to Week 80 |
| Effect of sabirnetug on Clinical Progression as Compared to Placebo Assessed Using Time Saved Analysis as Measured by MMSE | Baseline up to Week 80 |
| Percentage of Participants with No Clinical Progression at One Year | No clinical progression in participants will be defined as no decline in CDR-SB score. The CDR is obtained through semi-structured interviews of individuals with AD and informants. The ratings are obtained in six domains: memory, orientation, judgment & problem-solving, community affairs, home & hobbies, and personal care. Each domain is rated on a five-point scale of functioning as follows: 0 = no impairment; 0.5 = questionable impairment; 1 = mild impairment; 2 = moderate impairment; and 3 = severe impairment. CDR-SB score is obtained by summing each of the domain scores, with scores ranging from 0 to 18. Higher scores reflect greater cognitive and functional impairment. | Baseline up to Week 80 |
| Number of Participants with Treatment-Related Adverse Events (TEAEs) | Baseline up to Week 80 |
| Number of Participants with Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESI) | Baseline up to Week 80 |
| Number of Participants who Discontinue or Withdraw due to TEAE | Baseline up to Week 80 |
| Number of Participants with Anti-Drug Antibodies (ADA) and Neutralizing Antibodies | Baseline up to Week 80 |
| Number of Participants with Amyloid-Related Imaging Abnormality with Edema/Effusions (ARIA-E) and ARIA with Hemorrhage/Hemosiderin Deposition (ARIA-H) as Measured by Magnetic Resonance Imaging (MRI) | Baseline up to Week 80 |
| Number of Participants with Suicidal Ideation and Behavior as Measured by Columbia-Suicide Severity Rating Scale (C-SSRS) | The C-SSRS includes 'yes' or 'no' responses for assessment of suicidal ideation and behavior as well as numeric ratings for severity of ideation, if present (from 1 to 5, with 5 being the most severe). Greater lethality or potential lethality of suicidal behaviors (endorsed on the behavior subscale) indicates increased risk. | Baseline up to Week 80 |
| Serum Concentration of sabirnetug | Pre-dose and multiple timepoints post dose up to 80 weeks |
| Concentration of sabirnetug in Cerebrospinal Fluid (CSF) | Up to Week 76 |
| CSF Concentrations of ACU193 in a Subset of Participants | Up to Week 76 |
| Correlation Between sabirnetug Exposure with Clinical Efficacy Measures | Correlation between sabirnetug exposure and clinical outcomes (including iADRS, CDR-SB, ADCS-iADL, ADAS-Cog13, and MMSE) will be assessed in this study. | Baseline up to 80 weeks |
| Change From Baseline in Amyloid Plaque Load or Deposition Measured by Positron Emission Tomography (PET) in Centiloids | Baseline up to Week 76 |
| Change from Baseline in Volumetric Magnetic Resonance Imaging (vMRI) of Whole Brain Volume, Ventricular Volume, and Volume of Selected Regions of Interest | Baseline up to Week 76 |
| Target Engagement Assessed by Measurement of sabirnetug- Amyloid-β oligomer (AβO) Complex in CSF | Up to Week 76 |
| Change from Baseline in CSF Concentrations of Amyloid, Tau and Other Neurodegenerative Biomarkers | Baseline up to Week 76 |
| Change from Baseline in CSF Concentrations of Amyloid, Tau, and Other Neurodegenerative Biomarkers in a Subset of Participants | Baseline up to Week 76 |
| Change from Baseline in Blood Concentrations of Amyloid, Tau, and Other Neurodegenerative Biomarkers | Baseline up to Week 76 |
| Correlation Between Change in Biomarker that Reflect Disease Progression and Clinical Changes | Assessment of the correlation between change in clinical outcomes (iADRS, CDR-SB, ADCS-iADL, ADAS-Cog13, and MMSE) and change in biomarker (amyloid PET) will be determined by computing Pearson's correlation coefficient for each treatment group. | Up to 80 weeks |
| Neurology Center of North Orange County |
| Fullerton |
| California |
| 92835 |
| United States |
| Irvine Medical Research | Irvine | California | 92614 | United States |
| Healthy Brain Research | Long Beach | California | 90804 | United States |
| Syrentis Clinical Research | Santa Ana | California | 92705 | United States |
| CenExel - California Neuroscience Research Medical Group, Inc (CNR) | Sherman Oaks | California | 91403-2131 | United States |
| Research Center for Clinical Studies, LLC | Norwalk | Connecticut | 06851-4903 | United States |
| Re:Cognition Health - Fairfax | Washington D.C. | District of Columbia | 22031 | United States |
| JEM Research Institute | Atlantis | Florida | 33462 | United States |
| Bradenton Research Center | Bradenton | Florida | 34205 | United States |
| Gil Fernandez-Yera, MD, PA | Coral Gables | Florida | 33135 | United States |
| Brain Matters Research | Delray Beach | Florida | 33445 | United States |
| Coral Clinical Research | Homestead | Florida | 33032 | United States |
| K2 Medical Research - Villages | Lady Lake | Florida | 32159 | United States |
| Finlay Medical Research | Miami | Florida | 33126 | United States |
| Aqualane Clinical Research | Naples | Florida | 34105-8522 | United States |
| Ocala Health - Family Care Specialists - Ocala I | Ocala | Florida | 34470 | United States |
| Progressive Medical Research | Port Orange | Florida | 32127 | United States |
| Alzheimer's Research and Treatment Center - Stuart | Stuart | Florida | 34997 | United States |
| K2 Medical Research - Tampa | Tampa | Florida | 33607 | United States |
| Charter Research - Lady Lake | The Villages | Florida | 32162 | United States |
| Alzheimers Research and Treatment Center - Wellington | Wellington | Florida | 33414 | United States |
| Conquest Research | Winter Park | Florida | 32789 | United States |
| Charter Research - Winter Park | Winter Park | Florida | 32792 | United States |
| Columbus Memory Center | Columbus | Georgia | 31909 | United States |
| CenExel - iResearch Atlanta | Decatur | Georgia | 30030 | United States |
| Office of Jeffrey S. Ross, MD | Northbrook | Illinois | 60640 | United States |
| Boston Center for Memory | Newton | Massachusetts | 02459 | United States |
| Hattiesburg Clinic - Memory Center | Hattiesburg | Mississippi | 39401-7246 | United States |
| ActivMed Practices and Research | Portsmouth | New Hampshire | 03801 | United States |
| The Cognitive and Research Center of New Jersey | Springfield | New Jersey | 07081 | United States |
| CenExel - Advanced Memory Research Institute of NJ | Toms River | New Jersey | 08755 | United States |
| Neurological Associates of Albany | Albany | New York | 12208 | United States |
| AMC Research | Matthews | North Carolina | 28105 | United States |
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
| Summit Research Network | Portland | Oregon | 97210 | United States |
| Abington Neurological Associates | Abington | Pennsylvania | 19001 | United States |
| Keystone Clinical Research | Norristown | Pennsylvania | 19462 | United States |
| Rhode Island Mood and Memory | East Providence | Rhode Island | 02914 | United States |
| Neurology Clinic. P.C | Cordova | Tennessee | 38018 | United States |
| The Alliance for Multispecialty Research LLC (AMR) | Knoxville | Tennessee | 37920-1511 | United States |
| Senior Adult Specialty Research | Austin | Texas | 78757 | United States |
| Gadolin Research, LLC | Beaumont | Texas | 77702 | United States |
| Kerwin Medical Center | Dallas | Texas | 75231 | United States |
| Okanagan Clinical Trials | Kelowna | British Columbia | Canada |
| Hippocampe d/b/a Ottawa Memory Clinic | Ottawa | Ontario | Canada |
| Toronto Memory Program (TMP) (Neurology Research Inc.) | Toronto | Ontario | Canada |
| MoCA Research and Innovations | Greenfield Park | Quebec | Canada |
| Charité - Universitaetsmedizin Berlin | Berlin | Germany |
| University Hospital of Cologne | Cologne | Germany |
| Zentralinstitut für seelische Gesundheit | Mannheim | Germany |
| Technical University of Munich, School of Medicine and Health, Klinikum rechts der Isar | Munich | Germany |
| Hospital Universitari General de catalunya | Sant Cugat del Vallès | Barcelona | Spain |
| Fundacion Neuropolis - Hospital Viamed Montecanal | Cuarte de Huerva | Zaragoza | Spain |
| Fundacio ACE | Barcelona | Spain |
| Policlínica Gipuzkoa | Donostia / San Sebastian | Spain |
| Cae Oroitu | Getxo | Spain |
| Hospital Ruber | Madrid | Spain |
| Hospital Victoria Eugenia | Seville | Spain |
| Hospital Universitari i Politècnic La Fe | Valencia | Spain |
| Re:Cognition Health - London | London | Greater London | United Kingdom |
| St. Pancras Clinical Research Ltd. | London | Greater London | United Kingdom |
| Re:Cognition Health - Winchester | Winchester | Hampshire | United Kingdom |
| Neuroclin Glasgow | Motherwell | Lanarkshire | United Kingdom |
| Panthera Bio-Partners - Preston | Preston | Lancashire | United Kingdom |
| Re:Cognition Health - Guildford | Guildford | Surrey | United Kingdom |
| Panthera Biopartners - Sheffield | Sheffield | Yorkshire | United Kingdom |
| Re:Cognition Health - Bristol | Bristol | United Kingdom |
| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| D060825 | Cognitive Dysfunction |
| D008569 | Memory Disorders |
| 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 |
| D003072 | Cognition Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided