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TERMINATEDPHASE2

Study of ASN51 in Adults With Early Alzheimer's Disease

A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study of ASN51 in Adults With Early Alzheimer's Disease

NCT06677203•Asceneuron S.A.

View on ClinicalTrials.gov

Summary

The main purpose of this study is to evaluate the safety, tolerability, and effect on biomarkers of disease pathophysiology and pathology, pharmacokinetics (PK), and preliminary effects on measures of clinical efficacy of multiple doses of ASN51 in adult participants with early Alzheimer's disease (AD).

Eligibility

Age

50 - 80 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Male or female age 50 to 80 years.
•2. A clinical diagnosis of Alzheimer's disease (AD) at either the mild cognitive impairment or mild AD dementia stage per National Institute on Aging and the Alzheimer's Association, consistent with Stage 3 and Stage 4 in the Food and Drug Administration (FDA) draft guidance for early AD.
•3. Mini-Mental State Examination score of 20 to 28 (inclusive).
•4. A plasma pTau217 result consistent with the presence of amyloid pathology.
•5. Must have a care partner who, in the investigator's judgment, has frequent and sufficient contact with the participant as to be able to provide accurate information about the participant's cognitive and functional abilities. The care partner must be literate and provide informed consent.

Exclusion Criteria

•1. Any medical or neurological/neurodegenerative condition (other than AD) that, in the opinion of the Investigator, might be a contributing cause to the participant's cognitive impairment (e.g., current history of substance abuse, uncontrolled vitamin B12 deficiency or abnormal thyroid function, stroke or other cerebrovascular condition, normal pressure hydrocephalus, Parkinson's Disease, Lewy body dementia, cerebral amyloid angiopathy, frontotemporal dementia) or could lead to discontinuation, lack of compliance, interference with study assessments, or safety concerns.
•2. Non-amnestic presentation of AD as judged by the investigator.
•3. Woman of childbearing potential.
•4. Any prior or ongoing exposure to active or passive anti-amyloid immunotherapy, anti-tau immunotherapy, an anti-tau antisense oligonucleotide or gene therapy, or O-linked-β-N-acetylglucosaminidase (O-GlcNAcase) inhibitor.

Locations (7)

K2 Medical Research

Clermont, Florida, United States

K2 Medical Research - The Villages

Lady Lake, Florida, United States

K2 Medical Research

Maitland, Florida, United States

Alzheimer's Treatment and Research Center

Stuart, Florida, United States

Alzheimer's Treatment and Research Center

Wellington, Florida, United States

Columbus Memory Center, LLC

Columbus, Georgia, United States

Re:Cognition Health

Fairfax, Virginia, United States

Key Dates

Start Date

October 16, 2024

Primary Completion Date

November 8, 2024

Completion Date

November 8, 2024

Last Updated

June 29, 2025

Enrollment

123

ACTUAL participants

Conditions

Alzheimer Disease

Interventions

ASN51

DRUG

Placebo

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 29, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Study of ASN51 in Adults With Early Alzheimer's Disease

Inclusion Criteria

Exclusion Criteria

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