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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
Lead sponsor
Asset
ASN51
Listed sites
7
Recruiting sites
-
Enrollment
123
actual
Study population
Alzheimer’s disease
Key I/E criteria
•mild AD dementia•Amyloid biomarker required (plasma)•MMSE 20-28
Primary endpoints
•Adverse Events (AEs)•Columbia-Suicide Severity Rating Scale (C-SSRS)
Footprint
Where this trial recruits
Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.
Identifiers
Registered as
Timeline
Milestones
Assets
Drug assets
Study populations
Who this study enrolls
Eligibility
Who can enroll
Inclusion criteria
Key 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on Aging and the Alzheimer's Association, consistent with Stage 3 and Stage 4 in the Food and Drug Administration (FDA) draft guidance for early AD.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.
Other protocol defined inclusion and exclusion criteria could apply.
Endpoints (16)
What's being measured
Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.
Coverage by outcome category
Behavior / neuropsychiatric
2 endpointsChange From Baseline in Columbia-Suicide Severity Rating Scale (C-SSRS)
Time frame:Baseline up to Week 28
change from baseline, improvement
Change From Baseline in Columbia-Suicide Severity Rating Scale (C-SSRS)
Time frame:Baseline up to Week 28
change from baseline, improvement
Tau biomarkers
4 endpointsChange From Baseline in CSF Total Tau Protein Through Week 24
Time frame:Baseline through Week 24
change from baseline, improvement
Change From Baseline in MK-6240 Tau Positron Emission Tomography (PET) Signal Through Week 24
Time frame:Baseline through Week 24
change from baseline, improvement
Change From Baseline in CSF Total Tau Protein Through Week 24
Time frame:Baseline through Week 24
change from baseline, improvement
Change From Baseline in MK-6240 Tau Positron Emission Tomography (PET) Signal Through Week 24
Time frame:Baseline through Week 24
change from baseline, improvement
Fluid / digital biomarkers
2 endpointsChange From Baseline in Cerebrospinal Fluid (CSF) Plasma Tau Phosphorylated at Threonine-217 (pTau217) Through Week 24
Time frame:Baseline through Week 24
Phosphorylated tau 217 (p-tau217)
change from baseline, improvement
Change From Baseline in Cerebrospinal Fluid (CSF) Plasma Tau Phosphorylated at Threonine-217 (pTau217) Through Week 24
Time frame:Baseline through Week 24
Phosphorylated tau 217 (p-tau217)
change from baseline, improvement
Safety / tolerability / PK
6 endpointsNumber of Participants With Adverse Events (AEs)
Time frame:From first dose up to end of the study up to Week 28
event count, event
Number of Participants With Adverse Events (AEs)
Time frame:From first dose up to end of the study up to Week 28
event count, event
Trough Plasma Concentration (Cmin) of ASN51 in Plasma at Steady State
Time frame:Pre-dose on Day 1 and at multiple time points post-dose up to Week 24
concentration, descriptive
Maximum Plasma Concentration (Cmax) of ASN51 at Steady State
Time frame:Pre-dose on Day 1 and at multiple time points post-dose up to Week 24
concentration, descriptive
Trough Plasma Concentration (Cmin) of ASN51 in Plasma at Steady State
Time frame:Pre-dose on Day 1 and at multiple time points post-dose up to Week 24
concentration, descriptive
Maximum Plasma Concentration (Cmax) of ASN51 at Steady State
Time frame:Pre-dose on Day 1 and at multiple time points post-dose up to Week 24
concentration, descriptive
Other (unclassified)
2 endpointsChange From Baseline in Plasma pTau217 Through Week 24
Time frame:Baseline through Week 24
Phosphorylated tau 217 (p-tau217)
change from baseline, improvement
Change From Baseline in Plasma pTau217 Through Week 24
Time frame:Baseline through Week 24
Phosphorylated tau 217 (p-tau217)
change from baseline, improvement
Provenance
Sources
Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.