An Efficacy and Safety Study of ALZ-801 in APOE4/4 Early AD Subjects
Purpose
This study is being conducted to evaluate the safety and efficacy of ALZ-801 in Early Alzheimer's disease (AD) subjects with the APOE4/4 genotype. This is a double-blind, randomized trial with one dose of ALZ-801 compared to placebo.
Condition
- Early Alzheimer's Disease
Eligibility
- Eligible Ages
- Between 50 Years and 80 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Clinical diagnosis of MCI or Mild Dementia due to AD consistent with the National Institute on Aging-Alzheimer's Association (NIA-AA) Working Group Criteria. - Homozygous for the ε4 allele of the apolipoprotein E gene (APOE4/4). - MMSE score at Screening of 22 to 30 (inclusive). - CDR - Global score of 0.5 or 1 and CDR Memory Box Score of ≥ 0.5. - RBANS delayed memory index score ≤ 85. - Evidence of progressive memory loss over the last 12 months per investigator assessment
Exclusion Criteria
- Brain magnetic resonance imaging (MRI) indicative of significant abnormality per central reader, other than AD related atrophy. Computed tomography (CT) scan acceptable for subjects who cannot undergo MRI. - Diagnosis of neurodegenerative disorder other than AD. - Diagnosis of major depressive disorder (MDD) within one year prior to screening. - Currently taking memantine or has taken memantine within 12 weeks prior to the Baseline Visit. - History of suicidal behavior within one year prior to screening or has ongoing suicidal ideation. - History of seizures, excluding febrile seizures of childhood or a single distant seizure (> 5 years). - Medically confirmed history of recent cerebral infarct or transient ischemic attack within one year prior to screening.
Study Design
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Intervention Model Description
- This is a multi-center Phase 3, randomized, double-blind, placebo-controlled, parallel-group study.
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Masking Description
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental ALZ-801 |
ALZ-801 265 mg BID tablet orally. Subjects will receive placebo in the morning and one table of ALZ-801 265mg tablet in the evening during the first two weeks of the study; thereafter, they will receive a 265mg tablet BID. |
|
|
Placebo Comparator Placebo |
Subjects in the placebo treatment arm will receive placebo tablets BID throughout the study |
|
More Details
- Status
- Active, not recruiting
- Sponsor
- Alzheon Inc.
Study Contact
Detailed Description
This is a multi-center, double-blind study that will evaluate 265 mg BID of ALZ-801, an oral tablet, over 78 weeks as a treatment for subjects (50-80 years old) with Early AD who are homozygous for the ε4 allele of the apolipoprotein gene (APOE4 homozygous or APOE4/4). The primary efficacy outcome assessment is a measure of cognition (ADAS-cog 13). Additional measures of global and functional impairments will also be assessed. Imaging and soluble biomarkers of AD and neurodegeneration will be measured and a sub-study to evaluate cerebrospinal fluid (CSF) biomarkers is also included.