Clinical trial NCT06304883: Long-term Extension of Phase 3 Study of ALZ- 801 in APOE4/4 Early AD Subjects
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Early Alzheimer's Disease
Keywords: Dementia
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Alzheimer Disease
Lead sponsor: Alzheon Inc.
Sponsor class: INDUSTRY
First posted: 2024-03-12
Enrollment: 163
Sex: ALL
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This is a multi-center, open-label, single group, long-term extension study.
Primary purpose: TREATMENT

Brief 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.

Detailed 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, were eligible for enrollment. Subjects will be treated for 104 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Primary cognitive efficacy endpoint 1
timeFrame: Week 104
measure: Primary cognitive efficacy endpoint 2
timeFrame: Week 104
measure: Incidence, Nature, and Severity of Treatment Emergent Adverse events (TEAEs)
timeFrame: Week 104
measure: Primary imaging biomarker endpoint 1
timeFrame: Week 104
measure: Primary imaging biomarker endpoint 2
timeFrame: Week 104
Secondary outcomes:
measure: Secondary functional efficacy endpoint
timeFrame: Week 104
measure: Secondary functional efficacy endpoint
timeFrame: Week 104
measure: Secondary global assessment efficacy endpoint
timeFrame: Week 104
measure: Secondary cognitive efficacy endpoint 1
timeFrame: Week 104
measure: Secondary cognitive efficacy endpoint 2
timeFrame: Week 104
measure: Secondary cognitive efficacy endpoint 3
timeFrame: Week 104
measure: Secondary imaging biomarker endpoint
timeFrame: Week 104
measure: Secondary fluid biomarker endpoint
timeFrame: Week 104
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Xenoscience, Inc.
state: Arizona
city: Sun City
country: United States
facility: Banner Sun Health Research Institute
state: Arizona
city: Costa Mesa
country: United States
facility: ATP Clinical Research
state: California
city: Lomita
country: United States
facility: Torrance Clinical Research Institute
state: California
city: Sacramento
country: United States
facility: Sutter Health
state: California
city: Atlantis
country: United States
facility: JEM Research Institute, Headlands Site
state: Florida
city: Maitland
country: United States
facility: K2 Medical Research, LLC
state: Florida
city: Miami Beach
country: United States
facility: Mount Sinai Medical Center
state: Florida
city: Naples
country: United States
facility: Aqualane Clinical Research
state: Florida
city: Orlando
country: United States
facility: Charter Research
state: Florida
city: Port Orange
country: United States
facility: Progressive Medical Research
state: Florida
city: Stuart
country: United States
facility: ALZ Research and Treatment Center (A.R.T.C.)
state: Florida
city: Wellington
country: United States
facility: ALZ Research and Treatment Center (A.R.T.C.)
state: Florida
city: West Palm Beach
country: United States
facility: Premiere Research Institute
state: Florida
city: Columbus
country: United States
facility: Columbus Memory Center
state: Georgia
city: Fort Wayne
country: United States
facility: Fort Wayne Neurological Center
state: Indiana
city: Plymouth
country: United States
facility: Headlands Research Eastern MA
state: Massachusetts
city: Toms River
country: United States
facility: Advanced Memory Research Center
state: New Jersey
city: Albany
country: United States
facility: Neurological Associates of Albany
state: New York
city: New York
country: United States
facility: NYU Alzheimer's Disease Research Center
state: New York
city: Rochester
country: United States
facility: University of Rochester Medical Center
state: New York
city: Greensboro
country: United States
facility: Triad Clinical Trials
state: North Carolina
city: Matthews
country: United States
facility: AMC Research
state: North Carolina
city: Portland
country: United States
facility: Center for Cognitive Health
state: Oregon
city: Abington
country: United States
facility: Abington Neurological Associates
state: Pennsylvania
city: East Providence
country: United States
facility: Rhode Island Mood & Memory Research Institute
state: Rhode Island
city: Houston
country: United States
facility: UT Health Science Center at Houston
state: Texas
city: Fairfax
country: United States
facility: Re:Cognition Health
state: Virginia
city: Bellevue
country: United States
facility: Northwest Clinical Research Center
state: Washington
city: Kelowna
country: Canada
facility: OCT Research ULC (dba Okanagan Clinical Trials)
state: British Columbia
city: Halifax
country: Canada
facility: Centricity Research
state: Nova Scotia
city: Ottawa
country: Canada
facility: Recherches Neuro-Hippocampe Inc., d/b/a Ottawa Memory Clinic
state: Ontario
city: Peterborough
country: Canada
facility: Kawartha Centre - Redefining Healthy Aging
state: Ontario
city: Toronto
country: Canada
facility: Toronto Memory Program
state: Ontario
city: Plymouth
country: United Kingdom
facility: Re-Cognition Health Ltd Plymouth
state: Devon
city: London
country: United Kingdom
facility: Re-Cognition Health Ltd London
state: Greater London
city: Motherwell
country: United Kingdom
facility: NeuroClin Glasgow Ltd
state: North Lanarkshire
city: Guildford
country: United Kingdom
facility: Re-Cognition Health Ltd Guildford
state: Surrey
city: Birmingham
country: United Kingdom
facility: Re-Cognition Health Ltd Birmingham
state: West Midlands
city: Bristol
country: United Kingdom
facility: Re-Cognition Health Ltd Bristol
city: Winchester
country: United Kingdom
facility: Re-Cognition Health Ltd Winchester
Study officials:
affiliation: Alzheon Inc.
name: Susan Abushakra, MD
role: PRINCIPAL_INVESTIGATOR
References: