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Monoclonal Antibodies

ASN51 for Alzheimer's Disease

Phase 2
Recruiting
Research Sponsored by Asceneuron S.A.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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on Aging and the Alzheimer's Association, consistent with Stage 3 and Stage 4 in the Food and Drug Administration (FDA) draft guidance for early AD
Male or female age 50 to 80 years
Must not have
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline up to week 28

Summary

"This trial aims to test the safety and effectiveness of multiple doses of ASN51 in adults with early Alzheimer's disease. The study will look at how well the drug is tolerated, its effects on disease biom

Who is the study for?
This trial is for adults with early-stage Alzheimer's Disease. Participants should be in good general health, have a reliable caregiver, and must not be taking certain other medications that affect cognition.
What is being tested?
The study tests ASN51 against a placebo to assess its safety and impact on Alzheimer's biomarkers, how the body processes it, and any potential benefits on cognitive functions.
What are the potential side effects?
Possible side effects of ASN51 are not detailed here but generally may include reactions at the injection site, gastrointestinal issues, headaches, or changes in mood or behavior.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with early-stage Alzheimer's disease.
Select...
I am between 50 and 80 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have not been treated with any anti-amyloid or anti-tau therapies, or gene therapy.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline up to week 28
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline up to week 28 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change from Baseline in Columbia-Suicide Severity Rating Scale (C-SSRS)

Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: ASN51: Low DoseExperimental Treatment1 Intervention
Participants will receive low dose of ASN51 once daily (QD).
Group II: ASN51: High DoseExperimental Treatment1 Intervention
Participants will receive high dose of ASN51 QD.
Group III: PlaceboPlacebo Group1 Intervention
Participants will receive ASN51 matching placebo QD.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
ASN51
2021
Completed Phase 1
~70

Find a Location

Who is running the clinical trial?

Asceneuron S.A.Lead Sponsor
4 Previous Clinical Trials
90 Total Patients Enrolled
~52 spots leftby Sep 2026
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