Not provided
Not provided
Not provided
Not provided
Not provided
Strategic decision
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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).
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ASN51: Low Dose | Experimental | 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 | Experimental | 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 | Placebo Comparator | Participants were to receive ASN51 matching placebo orally, QD for up to 24 weeks in the double-blind placebo-controlled intervention period. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ASN51 | Drug | Oral capsules |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events (AEs) | An adverse event (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. | From first dose up to end of the study up to Week 28 |
| Change From Baseline in Columbia-Suicide Severity Rating Scale (C-SSRS) | 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). | Baseline up to Week 28 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
Key Inclusion Criteria:
Key Exclusion Criteria:
Other protocol defined inclusion and exclusion criteria could apply.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| K2 Medical Research | Clermont | Florida | 34711 | United States | ||
| K2 Medical Research - The Villages |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| FG002 | Placebo | Participants were to receive ASN51 matching placebo orally, QD for up to 24 weeks in the double-blind placebo-controlled intervention period. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | ASN51 Low Dose | Participants receive low 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. |
| BG001 | ASN51 High Dose |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Adverse Events (AEs) | An adverse event (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. | 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. | Posted | From first dose up to end of the study up to Week 28 |
|
AEs were not collected in this study.
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.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | ASN51 10 mg | Participants received 10 mg 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. |
Not provided
Not provided
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Asceneuron Clinical Research | Asceneuron S.A. | +41213538245 | clinicaltrials.gov@asceneuron.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 7, 2024 | Jun 13, 2025 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo |
| Drug |
Oral capsules |
|
| 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 in Plasma 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 |
| Lady Lake |
| Florida |
| 32159 |
| United States |
| K2 Medical Research | Maitland | Florida | 32751 | United States |
| Alzheimer's Treatment and Research Center | Stuart | Florida | 34997 | United States |
| Alzheimer's Treatment and Research Center | Wellington | Florida | 33414 | United States |
| Columbus Memory Center, LLC | Columbus | Georgia | 31909 | United States |
| Re:Cognition Health | Fairfax | Virginia | 22031 | United States |
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.
| BG002 | Placebo | Participants were to receive ASN51 matching placebo orally, QD for up to 24 weeks in the double-blind placebo-controlled intervention period. |
| BG003 | Total | Total of all reporting groups |
| Sex: Female, Male |
|
| Ethnicity (NIH/OMB) |
|
| Race (NIH/OMB) |
|
| Region of Enrollment | participants |
|
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.
| OG002 | Placebo | Participants were to receive ASN51 matching placebo orally, QD for up to 24 weeks in the double-blind placebo-controlled intervention period. |
|
| Primary | Change From Baseline in Columbia-Suicide Severity Rating Scale (C-SSRS) | 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). | 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. | Posted | Baseline up to Week 28 |
|
|
| Secondary | Change From Baseline in Cerebrospinal Fluid (CSF) Plasma Tau Phosphorylated at Threonine-217 (pTau217) Through Week 24 | 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. | Posted | Baseline through Week 24 |
|
|
| Secondary | Change From Baseline in CSF Total Tau Protein Through Week 24 | 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. | Posted | Baseline through Week 24 |
|
|
| Secondary | Change From Baseline in Plasma pTau217 Through Week 24 | 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. | Posted | Baseline through Week 24 |
|
|
| Secondary | Change From Baseline in MK-6240 Tau Positron Emission Tomography (PET) Signal Through Week 24 | 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. | Posted | Baseline through Week 24 |
|
|
| Secondary | Trough Plasma Concentration (Cmin) of ASN51 in Plasma at Steady State | 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. | Posted | Pre-dose on Day 1 and at multiple time points post-dose up to Week 24 |
|
|
| Secondary | Maximum Plasma Concentration (Cmax) of ASN51 at Steady State | 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. | Posted | Pre-dose on Day 1 and at multiple time points post-dose up to Week 24 |
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | ASN51 20 mg | Participants received 20 mg 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. | 0 | 0 | 0 | 0 | 0 | 0 |
| EG002 | Placebo | Participants received ASN51 matching placebo orally, QD for up to 24 weeks in the double-blind placebo-Controlled intervention period. | 0 | 0 | 0 | 0 | 0 | 0 |
Agreement finally allows PI to publish independently.
| D024801 |
| Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |