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

NCT06304883 | Active Not Recruiting Phase 3 FDA Drug

• 1 other identifier: ALZ-801-AD351
• Study Type: interventional
• Target: 163
• Locations: 3 countries
• Sites: 41

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.

Conditions

Early Alzheimer's Disease

Keywords

Dementia; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Alzheimer Disease

Outcome Measures

Primary Outcomes (5)

• 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 and Week 104 of this long-term extension study (ALZ-801-AD351).

  Week 104

• 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 and Week 104.

  Week 104

• 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 104

• Primary imaging biomarker endpoint 1

  Change from baseline in total hippocampal volume (mm3) as measured by Magnetic Resonance Imaging (MRI), from baseline of the Phase 3 core study (ALZ-801-AD301) to Week 52 and Week 104 of this long-term extension study (ALZ-801-AD351).

  Week 104

• 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 and Week 104.

  Week 104

Secondary Outcomes (8)

• Secondary functional efficacy endpoint

  Week 104

• Secondary functional efficacy endpoint

  Week 104

• Secondary global assessment efficacy endpoint

  Week 104

• Secondary cognitive efficacy endpoint 1

  Week 104

• Secondary cognitive efficacy endpoint 2

  Week 104

Study Arms (1)

Experimental: ALZ-801

EXPERIMENTAL

ALZ-801 265 mg BID tablet orally. Subjects will take one 265 mg tablet of ALZ-801 in the evening during the first 4 weeks of the study; thereafter, they will take one 265 mg tablet BID.

Drug: Experimental: ALZ-801

Interventions

Experimental: ALZ-801 DRUG

ALZ-801 265 mg BID tablet orally.

Experimental: ALZ-801

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Alzheon Inc.: lead

Study Sites (41)

Xenoscience, Inc.

Phoenix, Arizona, 85004, United States

Location

Banner Sun Health Research Institute

Sun City, Arizona, 85351, United States

Location

ATP Clinical Research

Costa Mesa, California, 92626, United States

Location

Torrance Clinical Research Institute

Lomita, California, 90717, United States

Location

Sutter Health

Sacramento, California, 95816, United States

Location

JEM Research Institute, Headlands Site

Atlantis, Florida, 33462, United States

Location

K2 Medical Research, LLC

Maitland, Florida, 32751, United States

Location

Mount Sinai Medical Center

Miami Beach, Florida, 33140, United States

Location

Aqualane Clinical Research

Naples, Florida, 34105, United States

Location

Charter Research

Orlando, Florida, 32803, United States

Location

Progressive Medical Research

Port Orange, Florida, 32127, United States

Location

ALZ Research and Treatment Center (A.R.T.C.)

Stuart, Florida, 34997, United States

Location

ALZ Research and Treatment Center (A.R.T.C.)

Wellington, Florida, 33414, United States

Location

Premiere Research Institute

West Palm Beach, Florida, 33407, United States

Location

Columbus Memory Center

Columbus, Georgia, 31909, United States

Location

Fort Wayne Neurological Center

Fort Wayne, Indiana, 46804, United States

Location

Headlands Research Eastern MA

Plymouth, Massachusetts, 02360, United States

Location

Advanced Memory Research Center

Toms River, New Jersey, 08755, United States

Location

Neurological Associates of Albany

Albany, New York, 12208, United States

Location

NYU Alzheimer's Disease Research Center

New York, New York, 10016, United States

Location

University of Rochester Medical Center

Rochester, New York, 14620, United States

Location

Triad Clinical Trials

Greensboro, North Carolina, 27410, United States

Location

AMC Research

Matthews, North Carolina, 28105, United States

Location

Center for Cognitive Health

Portland, Oregon, 97225, United States

Location

Abington Neurological Associates

Abington, Pennsylvania, 19001, United States

Location

Rhode Island Mood & Memory Research Institute

East Providence, Rhode Island, 02914, United States

Location

UT Health Science Center at Houston

Houston, Texas, 77054, United States

Location

Re:Cognition Health

Fairfax, Virginia, 22031, United States

Location

Northwest Clinical Research Center

Bellevue, Washington, 98007, United States

Location

OCT Research ULC (dba Okanagan Clinical Trials)

Kelowna, British Columbia, V1Y 1Z9, Canada

Location

Centricity Research

Halifax, Nova Scotia, B3S 1N2, Canada

Location

Recherches Neuro-Hippocampe Inc., d/b/a Ottawa Memory Clinic

Ottawa, Ontario, K1Z 1G3, Canada

Location

Kawartha Centre - Redefining Healthy Aging

Peterborough, Ontario, K9H 2P4, Canada

Location

Toronto Memory Program

Toronto, Ontario, M3B 2S7, Canada

Location

Re-Cognition Health Ltd Plymouth

Plymouth, Devon, PL6 8BT, United Kingdom

Location

Re-Cognition Health Ltd London

London, Greater London, W1G 9JF, United Kingdom

Location

NeuroClin Glasgow Ltd

Motherwell, North Lanarkshire, ML1 4UF, United Kingdom

Location

Re-Cognition Health Ltd Guildford

Guildford, Surrey, GU2 7YD, United Kingdom

Location

Re-Cognition Health Ltd Birmingham

Birmingham, West Midlands, B16 8LT, United Kingdom

Location

Re-Cognition Health Ltd Bristol

Bristol, BS32 4SY, United Kingdom

Location

Re-Cognition Health Ltd Winchester

Winchester, SO21 1HU, United Kingdom

Location

MeSH Terms

Conditions

Alzheimer Disease; Dementia; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Condition Hierarchy (Ancestors)

Brain Diseases

Study Officials

• Susan Abushakra, MD

  Alzheon Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This is a multi-center, open-label, single group, long-term extension study.

Study Record Dates

• First Submitted: March 5, 2024
• First Posted: March 12, 2024
• Study Start: April 2, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: October 31, 2025

Record last verified: 2025-10

Locations

CA (5); GB (7); US (29)