Clinical trial NCT06677203: Study of ASN51 in Adults With Early Alzheimer's Disease
Official title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study of ASN51 in Adults With Early Alzheimer's Disease
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Alzheimer Disease
Keywords: Alzheimer's Disease
ASN51
Lead sponsor: Asceneuron S.A.
Sponsor class: INDUSTRY
First posted: 2024-11-06
Enrollment: 123
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 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on Aging and the Alzheimer's Association, consistent with Stage 3 and Stage 4 in the Food and Drug Administration (FDA) draft guidance for early AD.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.

Key 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.

Primary outcomes:
measure: Number of Participants with Adverse Events (AEs)
timeFrame: From first dose of the study up to Week 28
measure: Change from Baseline in Columbia-Suicide Severity Rating Scale (C-SSRS)
timeFrame: Baseline up to Week 28
Secondary outcomes:
measure: Change From Baseline in Cerebrospinal Fluid (CSF) Plasma tau Phosphorylated at Threonine-217 (pTau217) Through Week 24
timeFrame: Baseline through Week 24
measure: Change From Baseline in CSF Total tau Protein Through Week 24
timeFrame: Baseline through Week 24
measure: Change From Baseline in Plasma pTau217 Through Week 24
timeFrame: Baseline through Week 24
measure: Change From Baseline in MK-6240 tau Positron Emission Tomography (PET) Signal Through Week 24
timeFrame: Baseline through Week 24
measure: Trough Plasma Concentration (Cmin) of ASN51 at Steady State
timeFrame: Pre-dose on Day 1 and at multiple time points post-dose up to Week 24
measure: Maximum Plasma Concentration (Cmax) of ASN51 at Steady State
timeFrame: Pre-dose on Day 1 and at multiple time points post-dose up to Week 24
Other outcomes:
Locations:
city: Clermont
country: United States
facility: K2 Medical Research
state: Florida
city: Lady Lake
country: United States
facility: K2 Medical Research - The Villages
state: Florida
city: Maitland
country: United States
facility: K2 Medical Research
state: Florida
city: Stuart
country: United States
facility: Alzheimer's Treatment and Research Center
state: Florida
city: Wellington
country: United States
facility: Alzheimer's Treatment and Research Center
state: Florida
city: Columbus
country: United States
facility: Columbus Memory Center, LLC
state: Georgia
city: Fairfax
country: United States
facility: Re:Cognition Health
state: Virginia
Study officials:
References: