Biomarker Effects of ALZ-801 in APOE4 Carriers With Early Alzheimer's Disease
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04693520|
Recruitment Status : Active, not recruiting
First Posted : January 5, 2021
Last Update Posted : March 17, 2023
- Study Details
- Tabular View
- No Results Posted
- How to Read a Study Record
|Condition or disease||Intervention/treatment||Phase|
|Early Alzheimer's Disease||Drug: ALZ-801||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||84 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 2, Single-arm Study of the Biomarker Effects of ALZ-801 in Subjects With Early Alzheimer's Disease Who Are Carriers of the ε4 Variant of the Apolipoprotein E Gene (APOE4/4 or APOE3/4)|
|Actual Study Start Date :||September 30, 2020|
|Estimated Primary Completion Date :||July 2023|
|Estimated Study Completion Date :||August 2023|
Experimental: Active treatment
ALZ-801 265 mg tablets once daily for two weeks and twice daily thereafter
ALZ-801 265 mg twice daily (BID)
- Plasma Biomarker of Core AD Pathology [ Time Frame: Week 104 ]Percent change from baseline in p-tau181
- Incidence, Nature, and Severity of Treatment Emergent Adverse events (TEAE) [ Time Frame: Week 108 ]Safety and tolerability as measured by incidence, nature and severity of treatment emergent adverse events (TEAE), serious TEAE, and TEAE leading to withdrawal.
- Volumetric Magnetic Resonance Imaging (vMRI) Biomarker - Hippocampal Volume [ Time Frame: Week 104 ]Change from baseline in hippocampal volume measured in mm3
- Plasma Biomarkers of AD and Neurodegeneration [ Time Frame: Week 104 ]Percent changes from baseline in: Aβ-40, Aβ-42,p-tau217 and plasma glial fibrillary acidic protein (GFAP),NfL
- vMRI Biomarker - Ventricular volume and Cortical Thickness [ Time Frame: Week 104 ]Change from baseline in cortical thickness measured in mm3
- Additional CSF Biomarkers of AD Pathology and Neurodegeneration [ Time Frame: Week 104 ]Percent changes from baseline for: p-tau217,Aβ-40, Aβ-42, NfL, t-tau, sTREM2, YKL-40 and neurogranin
- Cognitive assessment - Rey Auditory Verbal Learning Test (RAVLT) [ Time Frame: 104 weeks ]Change from baseline in RAVLT score
- Cognitive Assessment - Digit Symbol Substitution Test (DSST) [ Time Frame: 104 weeks ]Change from baseline in DSST score
- Functional Assessment - Amsterdam Instrumental Activities of Daily Living (A-IADL) [ Time Frame: 104 weeks ]Change from baseline in A-IADL score
- Cognitive Assessment - Mini Mental State Examination (MMSE) [ Time Frame: 104 weeks ]Change from baseline in MMSE score
- Global Assessment - Clinical Dementia Rating - Sum of Boxes (CDR-SB) [ Time Frame: 104 weeks ]Change from baseline in CDR-SB score
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||50 Years to 80 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Age between 50 and 80 years, inclusive.
- Early Alzheimer's Disease (AD): a diagnosis of Probable AD Dementia or Mild Cognitive Impairment (MCI) due to AD in accordance with the National Institute on Aging-Alzheimer's Association (NIA-AA) Working Group Criteria [Albert et al, 2011; McKhann et al, 2011].
- One of the following apolipoprotein E (APOE) genotypes - either APOE4/4 (homozygous) or APOE3/4 (heterozygous).
- MMSE score 22 to 30 inclusive; Clinical Dementia Rating (CDR)-Global Score of 0.5 or 1.0, and CDR Memory Box Score of ≥ 0.5.
- Documented confirmation of AD diagnosis by either positive amyloid positron emission tomography (PET) or positive CSF AD signature. Subjects without documented positive AD biomarker status must have a positive CSF biomarker result from a sample provided at screening.
- Stable doses of acetylcholinesterase for the duration of the study are allowed.
- Brain MRI at screening indicative of significant abnormality
- Diagnosis of neurodegenerative disorder other than AD
- Current diagnosis of Major Depressive Disorder (MDD)
- Concomitant treatment with memantine.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04693520
|St. Anne's University Hospital|
|Motol University Hospital|
|Rychnov Nad Kněžnou, Czechia|
|Brain Research Center|
|Brain Research Center|
|Den Bosch, Netherlands|
|Brain Research Center|
|Study Director:||John Hey, PhD||Alzheon Inc.|
|Responsible Party:||Alzheon Inc.|
|Other Study ID Numbers:||
|First Posted:||January 5, 2021 Key Record Dates|
|Last Update Posted:||March 17, 2023|
|Last Verified:||March 2023|
|Studies a U.S. FDA-regulated Drug Product:||Yes|
|Studies a U.S. FDA-regulated Device Product:||No|
Central Nervous System Diseases
Nervous System Diseases