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.
Eligibility
Sex
ALL
Min age
50 Years
Max age
90 Years
Healthy volunteers
No
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
1. National Institute on Aging-Alzheimer's Association (NIA-AA) criteria for mild cognitive impairment (MCI) due to Alzheimer's Disease (AD) or probable AD
2. Screening score between 22 and 30 (inclusive) on the Mini-Mental State Examination (MMSE)
3. Screening score of 0.5 or 1.0 on the Clinical Dementia Rating Global Score (CDR-GS) and Screening score ≥0.5 on the CDR Memory Box score
4. Evidence of cerebral amyloid accumulation by either PET scan or CSF
* 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:
1. Any suicide attempt or preparatory acts/behavior on the C-SSRS Baseline/Screening in the last six months
2. Suicidal ideation in the last six months as defined by a positive response to Question 5 (Suicidal Ideation) on the C-SSRS Baseline/Screening
3. Significant risk of suicide, as judged by the site investigator
* Conditions that may affect cognitive assessments during the study
* Alcohol use disorder and/or substance use disorder within the last five years
Primary outcome measure(s)
Change from Baseline in Integrated Alzheimer's Disease Rating Scale (iADRS) Score — Baseline up to Week 80 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.
Trial sites (68)
Facility
City
Region
Status
The Neurology Center of Southern California - Carlsbad
Carlsbad
California
Neurology Center of North Orange County
Fullerton
California
Irvine Medical Research
Irvine
California
Healthy Brain Research
Long Beach
California
Syrentis Clinical Research
Santa Ana
California
CenExel - California Neuroscience Research Medical Group, Inc (CNR)
Sherman Oaks
California
Research Center for Clinical Studies, LLC
Norwalk
Connecticut
Re:Cognition Health - Fairfax
Washington D.C.
District of Columbia
JEM Research Institute
Atlantis
Florida
Bradenton Research Center
Bradenton
Florida
Gil Fernandez-Yera, MD, PA
Coral Gables
Florida
Brain Matters Research
Delray Beach
Florida
Coral Clinical Research
Homestead
Florida
K2 Medical Research - Villages
Lady Lake
Florida
Finlay Medical Research
Miami
Florida
Aqualane Clinical Research
Naples
Florida
Ocala Health - Family Care Specialists - Ocala I
Ocala
Florida
Progressive Medical Research
Port Orange
Florida
Alzheimer's Research and Treatment Center - Stuart
Stuart
Florida
K2 Medical Research - Tampa
Tampa
Florida
Charter Research - Lady Lake
The Villages
Florida
Alzheimers Research and Treatment Center - Wellington
Wellington
Florida
Conquest Research
Winter Park
Florida
Charter Research - Winter Park
Winter Park
Florida
Columbus Memory Center
Columbus
Georgia
CenExel - iResearch Atlanta
Decatur
Georgia
Office of Jeffrey S. Ross, MD
Northbrook
Illinois
Boston Center for Memory
Newton
Massachusetts
Hattiesburg Clinic - Memory Center
Hattiesburg
Mississippi
ActivMed Practices and Research
Portsmouth
New Hampshire
The Cognitive and Research Center of New Jersey
Springfield
New Jersey
CenExel - Advanced Memory Research Institute of NJ
Toms River
New Jersey
Neurological Associates of Albany
Albany
New York
AMC Research
Matthews
North Carolina
Cleveland Clinic
Cleveland
Ohio
Summit Research Network
Portland
Oregon
Abington Neurological Associates
Abington
Pennsylvania
Keystone Clinical Research
Norristown
Pennsylvania
Rhode Island Mood and Memory
East Providence
Rhode Island
Neurology Clinic. P.C
Cordova
Tennessee
+ 28 more sites — see the full list on the official registry below.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time.