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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Experimental: ALZ-801 | Drug | ALZ-801 265 mg BID tablet orally. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Secondary functional efficacy endpoint | Change from baseline of the Phase 3 core study, and from baseline and from Week 52 of this study, in Disability Assessment for Dementia scores. | Week 104 |
| Secondary functional efficacy endpoint |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Susan Abushakra, MD | Alzheon Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xenoscience, Inc. | Phoenix | Arizona | 85004 | United States | ||
| Banner Sun Health Research Institute |
This is a multi-center, open-label, single group, long-term extension study.
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Change from baseline of the Phase 3 core study, and from baseline and from Week 52 of this study, in Amsterdam - Instrumental Activities of Daily Living scores.
| Week 104 |
| Secondary global assessment efficacy endpoint | Change from baseline of the Phase 3 core study, and from baseline and from Week 52 of this study, in Clinical Dementia Rating - Sum of Boxes (CDR-SB) scores. | Week 104 |
| Secondary cognitive efficacy endpoint 1 | Change from baseline of the Phase 3 core study, and from baseline and from Week 52 of this study, in Alzheimer's Disease Assessment Scale - Cognitive Subscale 11. | Week 104 |
| Secondary cognitive efficacy endpoint 2 | Change from baseline of the Phase 3 core study, and from baseline and from Week 52 of this study, in Neuropsychiatric Inventory. | Week 104 |
| Secondary cognitive efficacy endpoint 3 | Change from baseline of the Phase 3 core study, and from baseline and from Week 52 of this study, in Mini-Mental State Examination. | Week 104 |
| Secondary imaging biomarker endpoint | Change from baseline of the Phase 3 core study (ALZ-801-AD301) and from baseline of this long-term extension study (ALZ-801-AD351) in cortical thickness, whole brain volume and ventricular volume (mm3) as measured by Magnetic Resonance Imaging (MRI) to Weeks 26, 52, 78 and 104. | Week 104 |
| Secondary fluid biomarker endpoint | Change from baseline of the Phase 3 core study, and from baseline and from Week 52 of this study in plasma p-tau181, Aβ 42, Aβ 40, GFAP, and NfL levels. | Week 104 |
| Sun City |
| Arizona |
| 85351 |
| United States |
| ATP Clinical Research | Costa Mesa | California | 92626 | United States |
| Torrance Clinical Research Institute | Lomita | California | 90717 | United States |
| Sutter Health | Sacramento | California | 95816 | United States |
| JEM Research Institute, Headlands Site | Atlantis | Florida | 33462 | United States |
| K2 Medical Research, LLC | Maitland | Florida | 32751 | United States |
| Mount Sinai Medical Center | Miami Beach | Florida | 33140 | United States |
| Aqualane Clinical Research | Naples | Florida | 34105 | United States |
| Charter Research | Orlando | Florida | 32803 | United States |
| Progressive Medical Research | Port Orange | Florida | 32127 | United States |
| ALZ Research and Treatment Center (A.R.T.C.) | Stuart | Florida | 34997 | United States |
| ALZ Research and Treatment Center (A.R.T.C.) | Wellington | Florida | 33414 | United States |
| Premiere Research Institute | West Palm Beach | Florida | 33407 | United States |
| Columbus Memory Center | Columbus | Georgia | 31909 | United States |
| Fort Wayne Neurological Center | Fort Wayne | Indiana | 46804 | United States |
| Headlands Research Eastern MA | Plymouth | Massachusetts | 02360 | United States |
| Advanced Memory Research Center | Toms River | New Jersey | 08755 | United States |
| Neurological Associates of Albany | Albany | New York | 12208 | United States |
| NYU Alzheimer's Disease Research Center | New York | New York | 10016 | United States |
| University of Rochester Medical Center | Rochester | New York | 14620 | United States |
| Triad Clinical Trials | Greensboro | North Carolina | 27410 | United States |
| AMC Research | Matthews | North Carolina | 28105 | United States |
| Center for Cognitive Health | Portland | Oregon | 97225 | United States |
| Abington Neurological Associates | Abington | Pennsylvania | 19001 | United States |
| Rhode Island Mood & Memory Research Institute | East Providence | Rhode Island | 02914 | United States |
| UT Health Science Center at Houston | Houston | Texas | 77054 | United States |
| Re:Cognition Health | Fairfax | Virginia | 22031 | United States |
| Northwest Clinical Research Center | Bellevue | Washington | 98007 | United States |
| OCT Research ULC (dba Okanagan Clinical Trials) | Kelowna | British Columbia | V1Y 1Z9 | Canada |
| Centricity Research | Halifax | Nova Scotia | B3S 1N2 | Canada |
| Recherches Neuro-Hippocampe Inc., d/b/a Ottawa Memory Clinic | Ottawa | Ontario | K1Z 1G3 | Canada |
| Kawartha Centre - Redefining Healthy Aging | Peterborough | Ontario | K9H 2P4 | Canada |
| Toronto Memory Program | Toronto | Ontario | M3B 2S7 | Canada |
| Re-Cognition Health Ltd Plymouth | Plymouth | Devon | PL6 8BT | United Kingdom |
| Re-Cognition Health Ltd London | London | Greater London | W1G 9JF | United Kingdom |
| NeuroClin Glasgow Ltd | Motherwell | North Lanarkshire | ML1 4UF | United Kingdom |
| Re-Cognition Health Ltd Guildford | Guildford | Surrey | GU2 7YD | United Kingdom |
| Re-Cognition Health Ltd Birmingham | Birmingham | West Midlands | B16 8LT | United Kingdom |
| Re-Cognition Health Ltd Bristol | Bristol | BS32 4SY | United Kingdom |
| Re-Cognition Health Ltd Winchester | Winchester | SO21 1HU | United Kingdom |
| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| D003704 | Dementia |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D024801 | Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
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