An Efficacy and Safety Study of ALZ-801 in APOE4/4 Early AD Subjects (APOLLOE4)
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|ClinicalTrials.gov Identifier: NCT04770220|
Recruitment Status : Active, not recruiting
First Posted : February 25, 2021
Last Update Posted : March 28, 2023
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|Condition or disease||Intervention/treatment||Phase|
|Early Alzheimer's Disease||Drug: Experimental: ALZ-801 Drug: Placebo Comparator: Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||300 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||This is a multi-center Phase 3, randomized, double-blind, placebo-controlled, parallel-group study.|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Masking Description:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study of the Efficacy, Safety and Biomarker Effects of ALZ-801 in Subjects With Early Alzheimer's Disease and APOE4/4 Genotype|
|Actual Study Start Date :||May 19, 2021|
|Estimated Primary Completion Date :||May 31, 2024|
|Estimated Study Completion Date :||June 30, 2024|
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.
Drug: Experimental: ALZ-801
ALZ-801 tablet 265 mg BID
Placebo Comparator: Placebo
Subjects in the placebo treatment arm will receive placebo tablets BID throughout the study
Drug: Placebo Comparator: Placebo
Placebo tablet BID
- Primary cognitive efficacy endpoint [ Time Frame: Week 78 ]Change from baseline in Alzheimer's Disease Assessment Scale - Cognitive Subscale 13 (ADAS-cog 13) scores at 78 weeks
- Incidence, Nature, and Severity of Treatment Emergent Adverse events (TEAE) [ Time Frame: Week 78 ]Safety and tolerability as measured by incidence, nature and severity of treatment emergent adverse events (TEAE), serious TEAE, and TEAE leading to withdrawal.
- Primary fluid biomarker endpoint 1 [ Time Frame: Week 78 ]Change from baseline in cerebrospinal fluid p-tau181 levels in sub-study
- Primary fluid biomarker endpoint 2 [ Time Frame: Week 78 ]Change from baseline in plasma p-tau181 levels
- Primary imaging biomarker endpoint [ Time Frame: Week 78 ]Change from baseline in total hippocampal volume (mm3) as measured by Magnetic Resonance Imaging (MRI)
- Functional assessment 1 [ Time Frame: Week 78 ]Change from baseline in Amsterdam - Instrumental Activities of Daily Living scores
- Global assessment [ Time Frame: Week 78 ]Change from baseline in Clinical Dementia Rating - Sum of Boxes (CDR-SB) scores
- Functional assessment 2 [ Time Frame: Week 78 ]Change from baseline in Disability Assessment for Dementia (DAD)scores
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|Ages Eligible for Study:||50 Years to 80 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04770220
|Principal Investigator:||Susan Abushakra, MD||Alzheon Inc.|
|Responsible Party:||Alzheon Inc.|
|Other Study ID Numbers:||
R01AG065253 ( U.S. NIH Grant/Contract )
2020-005755-20 ( EudraCT Number )
|First Posted:||February 25, 2021 Key Record Dates|
|Last Update Posted:||March 28, 2023|
|Last Verified:||March 2023|
|Studies a U.S. FDA-regulated Drug Product:||Yes|
|Studies a U.S. FDA-regulated Device Product:||No|
Central Nervous System Diseases
Nervous System Diseases