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New pill targets Alzheimer's in High-Risk gene carriers

NCT ID NCT04693520

Disease control Sponsor: Alzheon Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested an oral drug called ALZ-801 in 84 people with early Alzheimer's who carry the APOE4 gene variant, which increases risk. Researchers measured changes in blood and brain scan markers of Alzheimer's over 65 weeks to see if the drug slows disease progression. The goal was to evaluate safety and effects on key Alzheimer's-related proteins.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

84 people

The number who actually took part.

Started

Sep 2020

Finished

Jul 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

50 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

Alzheimer disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Early Alzheimer's disease

Contacts and locations

Locations

  • Brain Research Center

    's-Hertogenbosch, Netherlands

  • Brain Research Center

    Amsterdam, Netherlands

  • Brain Research Center

    Zwolle, Netherlands

  • Motol University Hospital

    Prague, Czechia

  • St. Anne's University Hospital

    Brno, Czechia

  • Vestra Clinics

    Rychnov nad Kněžnou, Czechia

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