Trial Outcomes & Findings for Study of ASN51 in Adults With Early Alzheimer's Disease (NCT NCT06677203)
NCT ID: NCT06677203
Last Updated: 2025-06-29
Results Overview
An adverse event (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related.
TERMINATED
PHASE2
123 participants
From first dose up to end of the study up to Week 28
2025-06-29
Participant Flow
A total of 123 participants with Alzheimer's disease (AD) were enrolled in the study. The study was terminated due to a strategic decision by the sponsor before randomization and hence no participants received treatment, and no data were collected or evaluated for this study.
Participant milestones
| Measure |
ASN51 Low Dose
Participants were to receive low dose of ASN51 orally, once daily (QD) for up to 24 weeks in the double-blind placebo-controlled intervention period or up to 36 weeks long-term extension period.
|
ASN51 High Dose
Participants were to receive high dose of ASN51 orally, QD for up to 24 weeks in the double-blind placebo-controlled intervention period or up to 36 weeks long-term extension period.
|
Placebo
Participants were to receive ASN51 matching placebo orally, QD for up to 24 weeks in the double-blind placebo-controlled intervention period.
|
|---|---|---|---|
|
Overall Study
STARTED
|
0
|
0
|
0
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study of ASN51 in Adults With Early Alzheimer's Disease
Baseline characteristics by cohort
Baseline data not reported
PRIMARY outcome
Timeframe: From first dose up to end of the study up to Week 28Population: The study was terminated due to a strategic decision by the sponsor. No participants received treatment, and no data were collected or evaluated for this study.
An adverse event (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Baseline up to Week 28Population: The study was terminated due to a strategic decision by the sponsor. No participants received treatment, and no data were collected or evaluated for this study.
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).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline through Week 24Population: The study was terminated due to a strategic decision by the sponsor. No participants received treatment, and no data were collected or evaluated for this study.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline through Week 24Population: The study was terminated due to a strategic decision by the sponsor. No participants received treatment, and no data were collected or evaluated for this study.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline through Week 24Population: The study was terminated due to a strategic decision by the sponsor. No participants received treatment, and no data were collected or evaluated for this study.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline through Week 24Population: The study was terminated due to a strategic decision by the sponsor. No participants received treatment, and no data were collected or evaluated for this study.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Pre-dose on Day 1 and at multiple time points post-dose up to Week 24Population: The study was terminated due to a strategic decision by the sponsor. No participants received treatment, and no data were collected or evaluated for this study.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Pre-dose on Day 1 and at multiple time points post-dose up to Week 24Population: The study was terminated due to a strategic decision by the sponsor. No participants received treatment, and no data were collected or evaluated for this study.
Outcome measures
Outcome data not reported
Adverse Events
ASN51 10 mg
ASN51 20 mg
Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Agreement finally allows PI to publish independently.
- Publication restrictions are in place
Restriction type: OTHER