Overview

Biomarker Effects of ALZ-801 in APOE4 Carriers With Early Alzheimer's Disease

Status:
Active, not recruiting

Trial end date:
2023-08-01

Target enrollment:
0

Participant gender:
All

Summary

The study will investigate the effects of oral ALZ-801, in subjects with Early AD who have the APOE4/4 or APOE3/4 genotype, on the biomarkers of core AD pathology. The objectives of this study include determining the efficacy and safety/tolerability of ALZ-801. In addition, the study will evaluate the extended PK profile over 8 hours in 16 subjects after 65 weeks of treatment.

Phase:

Phase 2

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Alzheon Inc.

Criteria

Inclusion Criteria

1. Age between 50 and 80 years, inclusive.

2. Early Alzheimer's Disease (AD): a diagnosis of Probable AD Dementia or Mild Cognitive
Impairment (MCI) due to AD in accordance with the National Institute on
Aging-Alzheimer's Association (NIA-AA) Working Group Criteria [Albert et al, 2011;
McKhann et al, 2011].

3. One of the following apolipoprotein E (APOE) genotypes - either APOE4/4 (homozygous)
or APOE3/4 (heterozygous).

4. MMSE score 22 to 30 inclusive; Clinical Dementia Rating (CDR)-Global Score of 0.5 or
1.0, and CDR Memory Box Score of ≥ 0.5.

5. Documented confirmation of AD diagnosis by either positive amyloid positron emission
tomography (PET) or positive CSF AD signature. Subjects without documented positive AD
biomarker status must have a positive CSF biomarker result from a sample provided at
screening.

6. Stable doses of acetylcholinesterase for the duration of the study are allowed.

Exclusion Criteria

1. Brain MRI at screening indicative of significant abnormality

2. Diagnosis of neurodegenerative disorder other than AD

3. Current diagnosis of Major Depressive Disorder (MDD)

4. Concomitant treatment with memantine.