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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04693520
Other study ID # ALZ-801-201ADBM
Secondary ID
Status Active, not recruiting
Phase Phase 2
First received
Last updated
Start date September 30, 2020
Est. completion date August 2024

Study information

Verified date January 2024
Source Alzheon Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 84
Est. completion date August 2024
Est. primary completion date August 31, 2023
Accepts healthy volunteers No
Gender All
Age group 50 Years to 80 Years
Eligibility Inclusion Criteria 1. Age between 50 and 80 years, inclusive. 2. 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]. 3. One of the following apolipoprotein E (APOE) genotypes - either APOE4/4 (homozygous) or APOE3/4 (heterozygous). 4. 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. 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. 6. Stable doses of acetylcholinesterase for the duration of the study are allowed. Exclusion Criteria 1. Brain MRI at screening indicative of significant abnormality 2. Diagnosis of neurodegenerative disorder other than AD 3. Current diagnosis of Major Depressive Disorder (MDD) 4. Concomitant treatment with memantine.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
ALZ-801
ALZ-801 265 mg twice daily (BID)

Locations

Country Name City State
Czechia St. Anne's University Hospital Brno
Czechia Motol University Hospital Prague
Czechia Vestra Clinics Rychnov Nad Knežnou
Netherlands Brain Research Center Amsterdam
Netherlands Brain Research Center Den Bosch
Netherlands Brain Research Center Zwolle

Sponsors (1)

Lead Sponsor Collaborator
Alzheon Inc.

Countries where clinical trial is conducted

Czechia,  Netherlands, 

Outcome

Type Measure Description Time frame Safety issue
Other Cognitive assessment - Rey Auditory Verbal Learning Test (RAVLT) Change from baseline in RAVLT score Weeks 104 and 156
Other Cognitive Assessment - Digit Symbol Substitution Test (DSST) Change from baseline in DSST score Weeks 104 and 156
Other Functional Assessment - Amsterdam Instrumental Activities of Daily Living (A-IADL) Change from baseline in A-IADL score Weeks 104 and 156
Other Cognitive Assessment - Mini Mental State Examination (MMSE) Change from baseline in MMSE score Weeks 104 and 156
Other Global Assessment - Clinical Dementia Rating - Sum of Boxes (CDR-SB) Change from baseline in CDR-SB score Weeks 104 and 156
Primary Plasma Biomarker of Core AD Pathology Percent change from baseline in p-tau181 Week 104
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 108
Primary Volumetric Magnetic Resonance Imaging (vMRI) Biomarker - Hippocampal Volume Change from baseline in hippocampal volume measured in mm3 Week 104
Secondary Plasma Biomarkers of AD and Neurodegeneration Percent changes from baseline in: Aß-40, Aß-42,p-tau217 and plasma glial fibrillary acidic protein (GFAP),NfL Weeks 104 and 156
Secondary vMRI Biomarker - Ventricular volume and Cortical Thickness Change from baseline in cortical thickness measured in mm3 Weeks 104 and 156
Secondary Additional CSF Biomarkers of AD Pathology and Neurodegeneration Percent changes from baseline for: p-tau217,Aß-40, Aß-42, NfL, t-tau, sTREM2, YKL-40 and neurogranin Weeks 104 and 156
Secondary Plasma Biomarker of Core AD Pathology Percent change from baseline in p-tau181 Week 156
Secondary 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 160
Secondary Volumetric Magnetic Resonance Imaging (vMRI) Biomarker - Hippocampal Volume Change from baseline in hippocampal volume measured in mm3 Week 156
See also
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Enrolling by invitation NCT06304883 - Long-term Extension of Phase 3 Study of ALZ- 801 in APOE4/4 Early AD Subjects Phase 3