A Phase 2 interventional study of ALZ-801 in Early Alzheimer's Disease, sponsored by Alzheon Inc.. Completed at 6 sites in 2 countries. Open to participants aged 50 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-12-18.
Sponsored by Alzheon Inc. · Phase 2, Interventional, and Treatment
The study will investigate the effects of oral ALZ-801, in subjects with Early AD who have the APOE4/4 or APOE3/4 genotype, on the biomarkers of core AD pathology. The objectives of this study include determining the efficacy and safety/tolerability of ALZ-801. In addition, the study will evaluate the extended PK profile over 8 hours in 16 subjects after 65 weeks of treatment.
The LTE year 1 \& 2 study will investigate the effects of oral ALZ-801, in subjects with Early AD who have the APOE4/4 or APOE3/4 genotype, on the biomarkers of core AD pathology. The objectives of LTE study are to continue longitudinal assessment of the efficacy and safety/tolerability of ALZ-801 over a total period of 4 years (2-year Core study plus 2 years of LTE).
Core study: ALZ-801 265 mg twice daily (BID) in the Core Study, Weeks 0-104
LTE year 1: ALZ-801 265 mg BID in the Core Study and the Long-Term Extension (LTE, Weeks 104-208)
LTE year 2: ALZ-801 265mg BID in the Core Study and LTE Year 1 (Weeks 104-156), and LTE Year 2 (Weeks 156-208)
3,965 studies on the registry are indexed under Alzheimer Disease; 926 are open to participants now.
This study's enrollment of 84 is above the median of 70 across 3,019 interventional studies indexed under Alzheimer Disease.
Browse Alzheimer Disease studies →Alzheon Inc. is the lead sponsor of 6 studies on the registry; 1 is open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 1 (20%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
MMSE and MoCA
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALZ-801 265 mg tablets once daily for two weeks and twice daily thereafter
Drug: ALZ-801
ALZ-801 265 mg twice daily (BID)
Plasma Biomarker of Core AD Pathology
Percent change from baseline in p-tau181
Time frame: Week 104
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.
Time frame: Week 108
Volumetric Magnetic Resonance Imaging (vMRI) Biomarker - Hippocampal Volume
Change from baseline in hippocampal volume measured in mm3
Time frame: Weeks 104
Plasma Biomarkers of AD and Neurodegeneration
Percent changes from baseline in: Aβ-40, Aβ-42,p-tau217 and plasma glial fibrillary acidic protein (GFAP),NfL
Time frame: Weeks 104
vMRI Biomarker - Ventricular volume and Cortical Thickness
Change from baseline in cortical thickness measured in mm3
Time frame: Weeks 104, 156 and 208
Additional CSF Biomarkers of AD Pathology and Neurodegeneration
Percent changes from baseline for: p-tau217,Aβ-40, Aβ-42, NfL, t-tau, sTREM2, YKL-40 and neurogranin
Time frame: Weeks 104
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.
Time frame: Week 160 and week 212
Volumetric Magnetic Resonance Imaging (vMRI) Biomarker - Hippocampal Volume
Change from baseline in hippocampal volume measured in mm3
Time frame: Week 156 and week 208
Cognitive assessment - Rey Auditory Verbal Learning Test (RAVLT)
Change from baseline in RAVLT score
Time frame: Weeks 104, week 156 and week 208
Cognitive Assessment - Digit Symbol Substitution Test (DSST)
Change from baseline in DSST score
Time frame: Weeks 104, Week 156 and Week 208
Functional Assessment - Amsterdam Instrumental Activities of Daily Living (A-IADL)
Change from baseline in A-IADL score
Time frame: Weeks 104, Week 156 and Week 208
Cognitive Assessment - Mini Mental State Examination (MMSE)
Change from baseline in MMSE score
Time frame: Weeks 104, Week 156 and Week 208
Global Assessment - Clinical Dementia Rating - Sum of Boxes (CDR-SB)
Change from baseline in CDR-SB score
Time frame: Weeks 104, Week 156 and Week 208
This study is completed, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: ALZ-801
Alzheon Inc.