Early Alzheimer's Disease Clinical Trial
— APOLLOE4-LTEOfficial 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
Verified date | June 2024 |
Source | Alzheon Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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. |
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 |
Lead Sponsor | Collaborator |
---|---|
Alzheon Inc. |
United States, Canada, Czechia, France, Germany, Iceland, Netherlands, Spain, United Kingdom,
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 |
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