Study of ASN51 in Adults With Early Alzheimer's Disease
- Registration Number
- NCT06677203
- Lead Sponsor
- Asceneuron S.A.
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 123
- Male or female age 50 to 80 years.
- 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on Aging and the Alzheimer's Association, consistent with Stage 3 and Stage 4 in the Food and Drug Administration (FDA) draft guidance for early AD.
- Mini-Mental State Examination score of 20 to 28 (inclusive).
- A plasma pTau217 result consistent with the presence of amyloid pathology.
- 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
- 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.
- Non-amnestic presentation of AD as judged by the investigator.
- Woman of childbearing potential.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description ASN51: Low Dose ASN51 Participants will receive low dose of ASN51 once daily (QD). ASN51: High Dose ASN51 Participants will receive high dose of ASN51 QD. Placebo Placebo Participants will receive ASN51 matching placebo QD.
- Primary Outcome Measures
Name Time Method Number of Participants with Adverse Events (AEs) From first dose of the study up to Week 28 Change from Baseline in Columbia-Suicide Severity Rating Scale (C-SSRS) Baseline up to Week 28 C-SSRS is used to assess the suicidality of participants and assessment includes "yes" or "no" responses for 5 questions, each related to suicidal ideation and suicidal behavior. Numeric ratings are provided for suicidal ideation (score ranges from 1 to 5, where higher scores indicate more suicidal ideation) and suicidal behavior (score ranges from 0 to 4 where higher total scores indicate more suicidal behavior).
- Secondary Outcome Measures
Name Time Method Change From Baseline in Cerebrospinal Fluid (CSF) Plasma tau Phosphorylated at Threonine-217 (pTau217) Through Week 24 Baseline through Week 24 Change From Baseline in CSF Total tau Protein Through Week 24 Baseline through Week 24 Change From Baseline in Plasma pTau217 Through Week 24 Baseline through Week 24 Change From Baseline in MK-6240 tau Positron Emission Tomography (PET) Signal Through Week 24 Baseline through Week 24 Trough Plasma Concentration (Cmin) of ASN51 at Steady State Pre-dose on Day 1 and at multiple time points post-dose up to Week 24 Maximum Plasma Concentration (Cmax) of ASN51 at Steady State Pre-dose on Day 1 and at multiple time points post-dose up to Week 24
Trial Locations
- Locations (5)
K2 Medical Research
🇺🇸Maitland, Florida, United States
K2 Medical Research - The Villages
🇺🇸Lady Lake, 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