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

Early Alzheimer's Disease Clinical Trial

— APOLLOE4-LTE  

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06304883
• Other study ID #: ALZ-801-AD351
• Status: Enrolling by invitation
• Phase: Phase 3
• 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
• 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.

Related Conditions & MeSH terms

• Alzheimer Disease
• Early Alzheimer's Disease

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