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NCT06304883TerminatedPhase 3

Long-term Extension of Phase 3 Study of ALZ- 801 in APOE4/4 Early AD Subjects

Long-term Extension of 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

Source: ClinicalTrials.gov · Last updated 25 Jun 2026

Reason given: Sponsor business decision

Brief summary (registry, in English)

This study is being conducted to evaluate the long-term safety and efficacy of ALZ-801 in Early Alzheimer's disease (AD) subjects with the APOE4/4 genotype. This is an open-label trial of treatment with ALZ-801.

Status (registry)
Terminated
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
163 (actual)
First submitted
5 Mar 2024
Start date
2 Apr 2024
Primary completion date
11 Mar 2026
Lead sponsor
Alzheon Inc.
NCT number
NCT06304883

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Has received (or plans to receive) amyloid antibodies since completing Phase 3 core study (ALZ-801-AD301).
  • Subject taking any prohibited medications per protocol.

Other illness

  • Significant worsening of medical conditions that may preclude completion of this study.

Other

  • Evidence of symptomatic or new moderate-severe radiologic ARIA at baseline.

Who the study is looking for

  • Subject has completed the Week 78 of the Phase 3 core study (ALZ-801-AD301) while on study drug.
  • Subject has a reliable study partner who has sufficient contact with the subject to be able to provide accurate information about the subject's cognitive and functional abilities.

Age in the registry: 50 years to 85 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (41)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Centricity ResearchHalifaxCanadaUnknown status
OCT Research ULC (dba Okanagan Clinical Trials)KelownaCanadaUnknown status
Recherches Neuro-Hippocampe, Inc., d/b/a Ottawa Memory ClinicOttawaCanadaUnknown status
Kawartha Centre - Redefining Healthy AgingPeterboroughCanadaUnknown status
Toronto Memory ProgramTorontoCanadaUnknown status
Re-Cognition Health Ltd BirminghamBirminghamUnited KingdomUnknown status
Re:Cognition Health Ltd BristolBristolUnited KingdomUnknown status
Re-Cognition Health Ltd GuildfordGuildfordUnited KingdomUnknown status
Re:Cognition Health Ltd (London)LondonUnited KingdomUnknown status
NeuroClin Glasgow LtdMotherwellUnited KingdomUnknown status
Re-Cognition Health Ltd PlymouthPlymouthUnited KingdomUnknown status
Re-Cognition Health Ltd WinchesterWinchesterUnited KingdomUnknown status
Abington Neurological AssociatesAbingtonUnited StatesUnknown status
Neurological Associates of AlbanyAlbanyUnited StatesUnknown status
JEM Research Institute, Headlands SiteAtlantisUnited StatesUnknown status
Northwest Clinical Research CenterBellevueUnited StatesUnknown status
Columbus Memory CenterColumbusUnited StatesUnknown status
ATP Clinical ResearchCosta MesaUnited StatesUnknown status
Rhode Island Mood & Memory Research InstituteEast ProvidenceUnited StatesUnknown status
Re:Cognition HealthFairfaxUnited StatesUnknown status
Fort Wayne Neurological CenterFort WayneUnited StatesUnknown status
Triad Clinical TrialsGreensboroUnited StatesUnknown status
UT Health Science Center at HoustonHoustonUnited StatesUnknown status
Torrance Clinical Research InstituteLomitaUnited StatesUnknown status
K2 Medical Research, LLCMaitlandUnited StatesUnknown status
AMC ResearchMatthewsUnited StatesUnknown status
Mount Sinai Medical CenterMiami BeachUnited StatesUnknown status
Aqualane Clinical ResearchNaplesUnited StatesUnknown status
NYU Alzheimer's Disease Research CenterNew YorkUnited StatesUnknown status
Charter ResearchOrlandoUnited StatesUnknown status
Xenoscience Inc.PhoenixUnited StatesUnknown status
Headlands Research - Eastern MAPlymouthUnited StatesUnknown status
Center for Cognitive HealthPortlandUnited StatesUnknown status
Progressive Medical ResearchPort OrangeUnited StatesUnknown status
University of Rochester Medical CenterRochesterUnited StatesUnknown status
Sutter HealthSacramentoUnited StatesUnknown status
ALZ Research and Treatment Center (A.R.T.C.)StuartUnited StatesUnknown status
Banner Sun Health Research InstituteSun CityUnited StatesUnknown status
Advanced Memory Research CenterToms RiverUnited StatesUnknown status
ALZ Research and Treatment Center (A.R.T.C.)WellingtonUnited StatesUnknown status
Premiere Research InstituteWest Palm BeachUnited StatesUnknown status

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This page is information, not medical advice. Discuss any trial with your doctor.