NCT04693520CompletedPhase 2
Biomarker Effects of ALZ-801 in APOE4 Carriers With Early Alzheimer's Disease
A Phase 2, Single-arm Study of the Biomarker Effects of ALZ-801 in Subjects With Early Alzheimer's Disease Who Are Carriers of the ε4 Variant of the Apolipoprotein E Gene (APOE4/4 or APOE3/4)
Source: ClinicalTrials.gov · Last updated 18 Dec 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 84 (actual)
- First submitted
- 28 Dec 2020
- Start date
- 30 Sept 2020
- Primary completion date
- 20 Jun 2023
- Lead sponsor
- Alzheon Inc.
- Diseases
- Alzheimer disease
- NCT number
- NCT04693520
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 84
- From 30 Sept 2020 to the primary completion date, 20 Jun 2023
- 6 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Concomitant treatment with memantine.
Other illness
- Diagnosis of neurodegenerative disorder other than AD
- Current diagnosis of Major Depressive Disorder (MDD)
Other
- Brain MRI at screening indicative of significant abnormality
Who the study is looking for
- Age between 50 and 80 years, inclusive.
- 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 \[Albert et al, 2011; McKhann et al, 2011\].
- One of the following apolipoprotein E (APOE) genotypes - either APOE4/4 (homozygous) or APOE3/4 (heterozygous).
- 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.
- 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.
- Stable doses of acetylcholinesterase for the duration of the study are allowed.
Age in the registry: 50 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (6)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| St. Anne's University Hospital Coordinator of this site? Confirm its status | Brno | Czechia | Unknown status |
| Motol University Hospital Coordinator of this site? Confirm its status | Prague | Czechia | Unknown status |
| Vestra Clinics Coordinator of this site? Confirm its status | Rychnov nad Kněžnou | Czechia | Unknown status |
| Brain Research Center Coordinator of this site? Confirm its status | Amsterdam | Netherlands | Unknown status |
| Brain Research Center Coordinator of this site? Confirm its status | 's-Hertogenbosch | Netherlands | Unknown status |
| Brain Research Center Coordinator of this site? Confirm its status | Zwolle | Netherlands | Unknown status |
Related publications
This page is information, not medical advice. Discuss any trial with your doctor.