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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT06304883
Other study ID # ALZ-801-AD351
Secondary ID
Status Enrolling by invitation
Phase Phase 3
First received
Last updated
Start date April 2, 2024
Est. completion date January 2026

Study information

Verified date June 2024
Source Alzheon Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

This is a long-term extension study of the Phase 3, multicenter, randomized, double-blind, placebo-controlled study of the efficacy, safety, and imaging biomarker effects of ALZ-801 in subjects with Early Alzheimer's Disease and APOE4/4 genotype. Subjects who at initial screening for the Phase 3 study were 50-80 years old, had a clinical diagnosis of AD, carried the APOE4/4 genotype, and were at the early stage of disease (Early AD], who complete at least 78 weeks of the Phase 3 study while on study medication, are eligible for enrollment. Subjects will be treated for 52 weeks with ALZ-801, followed by a 4-week safety follow-up visit after the last dose of ALZ-801. Clinical trial sites, subjects and their study partner will remain blinded to the treatment (ALZ-801 or placebo) that they received in the core Phase 3 study. The primary efficacy outcome assessment is a measure of cognition (ADAS-Cog 13). Additional measures of global and functional impairments will also be assessed. Imaging and biomarkers of AD and neurodegeneration will be measured.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 285
Est. completion date January 2026
Est. primary completion date December 2025
Accepts healthy volunteers No
Gender All
Age group 50 Years to 85 Years
Eligibility Inclusion Criteria: - 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. Exclusion Criteria: - Significant worsening of medical conditions that may preclude completion of this study. - Evidence of symptomatic or new moderate-severe radiologic ARIA at baseline. - Has received (or plans to receive) amyloid antibodies since completing Phase 3 core study (ALZ-801-AD301). - Subject taking any prohibited medications per protocol.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Experimental: ALZ-801
ALZ-801 265 mg BID tablet orally.

Locations

Country Name City State
Canada Centricity Research Halifax Nova Scotia
Canada OCT Research ULC (dba Okanagan Clinical Trials) Kelowna British Columbia
Canada Recherches Neuro-Hippocampe Inc., d/b/a Ottawa Memory Clinic Ottawa Ontario
Canada Kawartha Centre - Redefining Healthy Aging Peterborough Ontario
Canada Toronto Memory Program Toronto Ontario
Czechia Fakultní nemocnice u sv. Anny v Brne (St. Anne's University Hospital) Brno
France Centre Hospitalier Universitaire de Marseille - Hôpital de la Timone Marseille
France Hopital Gui de Chauliac - CHRU de Montpellier Montpellier Cedex 5
France Fernand Widal -Lariboisière Hospital - APHP NORD Paris Cedex 10
France Centre Hospitalier Universitaire (CHU) Hopitaux de Rouen Rouen
France Hopitaux Universitaires de Strasbourg Centre d'Investigation Clinique Strasbourg
France Centre de Recherche Clinique du Gerontopole - CHU Toulouse Toulouse
France Institut du Vieillissement Centre Memoire Ressources Recherche de Lyon -Charpennes Hospital Villeurbanne
Germany Universitätsklinik fuer Psychiatrie und Psychotherapie Tuebingen
Iceland Memory Clinic, Landspitali University Hospital Reykjavík
Netherlands Brain Research Center Amsterdam Amsterdam
Netherlands Brain Research Center Den Bosch Den Bosch
Netherlands Brain Research Center Zwolle Zwolle
Spain Fundacia ACE - Institut Catala de Neurociencies Aplicadas Barcelona
Spain Hospital Clinico San Carlos Madrid
Spain Clinica Universidad de Navarra Pamplona
Spain Hospital Universitari MutuaTerrassa Terrassa
Spain Centro Hospital Universitario Dr. Preset Valencia
United Kingdom Re-Cognition Health Ltd Birmingham Birmingham West Midlands
United Kingdom Re-Cognition Health Ltd Bristol Bristol
United Kingdom Re-Cognition Health Ltd Guildford Guildford Surrey
United Kingdom Re-Cognition Health Ltd London London Greater London
United Kingdom NeuroClin Glasgow Ltd Motherwell North Lanarkshire
United Kingdom Re-Cognition Health Ltd Plymouth Plymouth Devon
United Kingdom Re-Cognition Health Ltd Winchester Winchester
United States Abington Neurological Associates Abington Pennsylvania
United States Neurological Associates of Albany Albany New York
United States JEM Research Institute, Headlands Site Atlantis Florida
United States Northwest Clinical Research Center Bellevue Washington
United States Bradenton Research Center Bradenton Florida
United States Columbus Memory Center Columbus Georgia
United States ATP Clinical Research Costa Mesa California
United States Rhode Island Mood & Memory Research Institute East Providence Rhode Island
United States Re:Cognition Health Fairfax Virginia
United States Fort Wayne Neurological Center Fort Wayne Indiana
United States Triad Clinical Trials Greensboro North Carolina
United States UT Health Science Center at Houston Houston Texas
United States Alphab Global Research Jupiter Florida
United States Torrance Clinical Research Institute Lomita California
United States K2 Medical Research, LLC Maitland Florida
United States AMC Research Matthews North Carolina
United States Mount Sinai Medical Center Miami Beach Florida
United States Aqualane Clinical Research Naples Florida
United States NYU Alzheimer's Disease Research Center New York New York
United States Kline Institute for Psychiatric Research Orangeburg New York
United States Charter Research Orlando Florida
United States Headlands Research Orlando Orlando Florida
United States Xenoscience, Inc. Phoenix Arizona
United States Headlands Research Eastern MA Plymouth Massachusetts
United States Progressive Medical Research Port Orange Florida
United States Center for Cognitive Health Portland Oregon
United States University of Rochester Medical Center Rochester New York
United States Sutter Health Sacramento California
United States ALZ Research and Treatment Center (A.R.T.C.) Stuart Florida
United States Banner Sun Health Research Institute Sun City Arizona
United States Advanced Memory Research Center Toms River New Jersey
United States ALZ Research and Treatment Center (A.R.T.C.) Wellington Florida
United States Premiere Research Institute West Palm Beach Florida

Sponsors (1)

Lead Sponsor Collaborator
Alzheon Inc.

Countries where clinical trial is conducted

United States,  Canada,  Czechia,  France,  Germany,  Iceland,  Netherlands,  Spain,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Primary cognitive efficacy endpoint 1 Change from baseline in Alzheimer's Disease Assessment Scale - Cognitive Subscale 13 (ADAS-Cog 13), from baseline of Phase 3 core study (ALZ-801-AD301) to Week 52 of this long-term extension study (ALZ-801-AD351). Week 52
Primary Primary cognitive efficacy endpoint 2 Change from baseline in Alzheimer's Disease Assessment Scale - Cognitive Subscale 13 (ADAS-Cog 13), from baseline of this study to Week 52. Week 52
Primary Incidence, Nature, and Severity of Treatment Emergent Adverse events (TEAEs) Safety and tolerability as measured by incidence, nature and severity of treatment emergent adverse events (TEAE), serious TEAE, and TEAE leading to withdrawal. Week 52
Primary Primary imaging biomarker endpoint 1 Change from baseline in total hippocampal volume (mm3) as measured by Magnetic Resonance Imaging (MRI), from baseline of Phase 3 core study (ALZ-801-AD301) to Week 52 of this long-term extension study (ALZ-801-AD351). Week 52
Primary Primary imaging biomarker endpoint 2 Change from baseline in total hippocampal volume (mm3) as measured by Magnetic Resonance Imaging (MRI), from baseline of this study to Week 52. Week 52
Secondary Secondary functional efficacy endpoint Change from baseline in Amsterdam - Instrumental Activities of Daily Living scores Week 52
Secondary Secondary global assessment efficacy endpoint Change from baseline in Clinical Dementia Rating - Sum of Boxes (CDR-SB) scores Week 52
Secondary Secondary cognitive efficacy endpoint 1 Change from baseline in Alzheimer's Disease Assessment Scale - Cognitive Subscale 11 Week 52
Secondary Secondary cognitive efficacy endpoint 2 Change from baseline in Neuropsychiatric Inventory Week 52
Secondary Secondary cognitive efficacy endpoint 3 Change from baseline in Mini-Mental State Examination Week 52
Secondary Secondary imaging biomarker endpoint Change from baseline in cortical thickness and ventricular volume (mm3) as measured by Magnetic Resonance Imaging (MRI) Week 52
Secondary Secondary fluid biomarker endpoint Change from baseline in plasma p-tau181, Aß 42, and Aß 40 levels Week 52
See also
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Active, not recruiting NCT04770220 - An Efficacy and Safety Study of ALZ-801 in APOE4/4 Early AD Subjects Phase 3
Active, not recruiting NCT04777396 - A Research Study Investigating Semaglutide in People With Early Alzheimer's Disease (EVOKE) Phase 3
Active, not recruiting NCT03887455 - A Study to Confirm Safety and Efficacy of Lecanemab in Participants With Early Alzheimer's Disease Phase 3
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