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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04770220
Other study ID # ALZ-801-AD301
Secondary ID R01AG0652532020-
Status Active, not recruiting
Phase Phase 3
First received
Last updated
Start date May 19, 2021
Est. completion date June 30, 2024

Study information

Verified date May 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 safety and efficacy of ALZ-801 in Early Alzheimer's disease (AD) subjects with the APOE4/4 genotype. This is a double-blind, randomized trial with one dose of ALZ-801 compared to placebo.


Description:

This is a multi-center, double-blind study that will evaluate 265 mg BID of ALZ-801, an oral tablet, over 78 weeks as a treatment for subjects (50-80 years old) with Early AD who are homozygous for the ε4 allele of the apolipoprotein gene (APOE4 homozygous or APOE4/4). 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 soluble biomarkers of AD and neurodegeneration will be measured and a sub-study to evaluate cerebrospinal fluid (CSF) biomarkers is also included.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 300
Est. completion date June 30, 2024
Est. primary completion date May 31, 2024
Accepts healthy volunteers No
Gender All
Age group 50 Years to 80 Years
Eligibility Inclusion Criteria: - Clinical diagnosis of MCI or Mild Dementia due to AD consistent with the National Institute on Aging-Alzheimer's Association (NIA-AA) Working Group Criteria. - Homozygous for the e4 allele of the apolipoprotein E gene (APOE4/4). - MMSE score at Screening of 22 to 30 (inclusive). - CDR - Global score of 0.5 or 1 and CDR Memory Box Score of = 0.5. - RBANS delayed memory index score = 85. - Evidence of progressive memory loss over the last 12 months per investigator assessment Exclusion Criteria: - Brain magnetic resonance imaging (MRI) indicative of significant abnormality per central reader, other than AD related atrophy. Computed tomography (CT) scan acceptable for subjects who cannot undergo MRI. - Diagnosis of neurodegenerative disorder other than AD. - Diagnosis of major depressive disorder (MDD) within one year prior to screening. - Currently taking memantine or has taken memantine within 12 weeks prior to the Baseline Visit. - History of suicidal behavior within one year prior to screening or has ongoing suicidal ideation. - History of seizures, excluding febrile seizures of childhood or a single distant seizure (> 5 years). - Medically confirmed history of recent cerebral infarct or transient ischemic attack within one year prior to screening.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Experimental: ALZ-801
ALZ-801 tablet 265 mg BID
Placebo Comparator: Placebo
Placebo tablet BID

Locations

Country Name City State
Canada Recherches Neuro-Hippocampe Inc. d/b/a Clinique de la Mémoire de l'Outaouais Gatineau Quebec
Canada Centricity Research Halifax Nova Scotia
Canada OCT Research ULC (dba Okanagan Clinical Trials) Kelowna British Columbia
Canada Centricity Research New Minas Nova Scotia
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
Czechia Medica 111, Spol. s r.o. - Neurologicka a Rehabilitacni Ambulance Brno, Centralni Pracoviste v Brne Brno
Czechia Neuropsychiatrie s.r.o. Praha
Czechia Vestra Clinics - Dedicated Research Clinics Rychnov Nad Knežnou
France Centre Hospitalier Universitaire de Marseille - Hôpital de la Timone Marseille
France Hopital Gui de Chauliac - CHRU de Montpellier Montpellier Cedex 5
France Hopital Lariboisiere - Fernand-Widal - AP-HP 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 Centre de Recherche-Hopital Geriatrique de Charpennes Villeurbanne
Germany University Hospital RWTH Aachen Neurological Study Center Aachen
Germany Klinikum der Universitaet Muenchen Innenstadt Muenchen
Germany Universitätsklinik fuer Psychiatrie und Psychotherapie Tuebingen
Germany Studienzentrum Nord-West Westerstede
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 Clinica Universidad de Navarra Madrid
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 St. Pancras Clinical Research 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 Lehigh Center for Clinical Research Allentown Pennsylvania
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 NeuroScience Research Center Canton Ohio
United States Columbus Memory Center Columbus Georgia
United States ATP Clinical Research Costa Mesa California
United States Neurology Diagnostics Dayton Ohio
United States Accel Research Sites Decatur Georgia
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 Galiz Research Hialeah Florida
United States UT Health Science Center at Houston Houston Texas
United States Alphab Global Research Jupiter Florida
United States UCSD Shiley-Marcos Alzheimer's Disease Research Center La Jolla California
United States Charter Research Lady Lake Florida
United States Wake Research - Clinical Research Center of Nevada Las Vegas Nevada
United States Torrance Clinical Research Institute Lomita California
United States Collaborative NeuroScience Network LLC Long Beach California
United States K2 Medical Research, LLC Maitland Florida
United States AMC Research Matthews North Carolina
United States Miami Jewish Health Miami Florida
United States Y & L Advance Health Care, Inc /DBA Elite Clinical Research Miami Florida
United States Mount Sinai Medical Center Miami Beach Florida
United States Medical College of Wisconsin Milwaukee Wisconsin
United States Aqualane Clinical Research Naples Florida
United States Vanderbilt University Medical Center Nashville Tennessee
United States NYU Alzheimer's Disease Research Center New York New York
United States IPS Research Oklahoma City Oklahoma
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 Advanced Research Consultants Palm Beach Gardens Florida
United States Stanford University Palo Alto California
United States SC3 Research Group Pasadena California
United States Xenoscience Phoenix Arizona
United States Headlands Research Eastern MA Plymouth Massachusetts
United States Quantum CNS Clinical Research Pompano Beach Florida
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 CCT Research Scottsdale Arizona
United States Louisiana State University Health Sciences Center (LSUHSC) Shreveport Louisiana
United States Richmond Behavioral Associates Staten Island New York
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 Tilda Research, Inc. Tustin California
United States ALZ Research and Treatment Center (A.R.T.C.) Wellington Florida
United States Premiere Research Institute West Palm Beach Florida

Sponsors (2)

Lead Sponsor Collaborator
Alzheon Inc. National Institute on Aging (NIA)

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 Change from baseline in Alzheimer's Disease Assessment Scale - Cognitive Subscale 13 (ADAS-cog 13) scores at 78 weeks Week 78
Primary Incidence, Nature, and Severity of Treatment Emergent Adverse events (TEAE) Safety and tolerability as measured by incidence, nature and severity of treatment emergent adverse events (TEAE), serious TEAE, and TEAE leading to withdrawal. Week 78
Primary Primary fluid biomarker endpoint 1 Change from baseline in cerebrospinal fluid p-tau181 levels in sub-study Week 78
Primary Primary fluid biomarker endpoint 2 Change from baseline in plasma p-tau181 levels Week 78
Primary Primary imaging biomarker endpoint Change from baseline in total hippocampal volume (mm3) as measured by Magnetic Resonance Imaging (MRI) Week 78
Secondary Functional assessment 1 Change from baseline in Amsterdam - Instrumental Activities of Daily Living scores Week 78
Secondary Global assessment Change from baseline in Clinical Dementia Rating - Sum of Boxes (CDR-SB) scores Week 78
Secondary Functional assessment 2 Change from baseline in Disability Assessment for Dementia (DAD)scores Week 78
See also
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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
Recruiting NCT05531656 - A Study to Evaluate the Safety and Efficacy of CT1812 in Early Alzheimer's Disease Phase 2
Recruiting NCT04599764 - High Definition Transcranial Direct Current Stimulation (HD-tDCS) for Early Alzheimer's Disease N/A
Completed NCT05161715 - Proof-of-concept, Open-label Study in Patients With Early Alzheimer's Disease Phase 2
Completed NCT02859207 - A Study to Evaluate the Pharmacokinetics of E2609 and Its Metabolites in Subjects With Mild and Moderate Hepatic Impairment Compared With Healthy Subjects Phase 1
Enrolling by invitation NCT06304883 - Long-term Extension of Phase 3 Study of ALZ- 801 in APOE4/4 Early AD Subjects Phase 3