Study of ASN51 in Adults With Early Alzheimer's Disease
Megadott ok: Strategic decision
Key facts
- Where
- Clermont, Columbus, Fairfax, Lady Lake, Maitland, Stuart és Wellington, Egyesült ÁllamokSee the 7 sites
- Phase
- 2. fázis
Where in Egyesült Államok
- K2 Medical ResearchClermont, Egyesült ÁllamokNo longer taking part
- Columbus Memory Center, LLCColumbus, Egyesült ÁllamokNo longer taking part
- Re:Cognition HealthFairfax, Egyesült ÁllamokNo longer taking part
- K2 MEDICAL Research THE VILLAGESLady Lake, Egyesült ÁllamokNo longer taking part
- K2 Medical ResearchMaitland, Egyesült ÁllamokNo longer taking part
- Alzheimer's Treatment and Research CenterStuart, Egyesült ÁllamokNo longer taking part
- Alzheimer's Treatment and Research CenterWellington, Egyesült ÁllamokNo longer taking part
Trial details
- Who runs it
- Asceneuron S.A.
- Trial code
- NCT06677203
- Record updated
- 2025. június 29.
- Original description
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).Read full original descriptionShow less
A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study of ASN51 in Adults With Early Alzheimer's Disease
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).
Inclusion: 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on Aging and the Alzheimer's Association, consistent with Stage 3 and Stage 4 in the Food and Drug Administration (FDA) draft guidance for early AD; Mini-Mental State Examination score of 20 to 28 (inclusive); A plasma pTau217 result consistent with the presence of amyloid pathology; Must have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.
Exclusion: 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; 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.