Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The primary purpose of this study is to evaluate the safety and tolerability of SAGE-718 and its effects on cognitive and neuropsychiatric symptoms in participants with mild cognitive impairment (MCI) or mild dementia due to Alzheimer's disease (AD).
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SAGE-718 | Experimental | Participants received SAGE-718 3 mg oral tablets, once daily in the morning for 14 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SAGE-718 | Drug | SAGE-718 oral tablets. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | An adverse event (AE) was any untoward medical occurrence in a participant administered with a pharmaceutical product and that does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an IP whether or not related to the product. An AE can include any undesirable medical condition, even if no study treatment has been administered. TEAEs were defined as an AE with an onset date on or after the date of the first dose of IP or any worsening of a pre-existing medical condition/AE with onset after the start of IP and throughout the study. | From first dose of study drug up to last follow up visit (up to 28 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With at Least One Potentially Clinically Significant (PCS) Change in Vital Signs Measurements | PCS changes for vital signs included: Supine Systolic Blood Pressure (SBP) >180 millimeters of mercury (mmHg), SBP decrease from baseline of ≥ 30 mmHg, standing 1-minute SBP >180 mmHg, standing 3 minutes SBP decrease from baseline of ≥ 30 mmHg, Supine diastolic BP (DBP) decrease from baseline of ≥ 20 mmHg, standing 1-minute DBP decrease from baseline of ≥ 20 mmHg, standing 1-minute DBP increase from baseline of ≥ 20 mmHg, standing 3-minute DBP increase from baseline of ≥ 20 mmHg, orthostatic SBP: supine-1 minute standing ≥ 20 mmHg and supine-3 minute standing ≥ 20 mmHg, orthostatic DBP: supine-1 minute standing ≥ 10 mmHg and supine-3 minute standing ≥ 10 mmHg. Percentage of participants with at least one PCS change in vital signs measurements were reported. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sage Investigational Site | Phoenix | Arizona | 85044 | United States | ||
| Sage Investigational Site |
Data sharing will be consistent with the results submission policy of ClinicalTrials.gov.
Not provided
Not provided
Not provided
Not provided
A total of 58 participants were screened, of which 26 participants were enrolled to receive SAGE-718.
Participants were enrolled at investigative sites in the United States from 07 December 2020 to 28 September 2021.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | SAGE-718 | Participants received SAGE-718 3 mg oral tablets, once daily in the morning for 14 days. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 24, 2020 | Aug 30, 2024 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| From first dose of study drug up to last follow-up visit (up to 28 days) |
| Percentage of Participants With at Least One Potentially Clinically Significant Change in Laboratory Assessments | PCS changes for laboratory assessments included: hematology: hematocrit- male low (<0.385 fractions of 1), hemoglobin male low (<115 grams per liter [g/L]) and biochemistry: glucose high (>13.9 millimoles per liter [mmol/L]), potassium low (<3.3 mmol/L), blood urea nitrogen high (>10.71 mmol/L)., Percentage of participants with at least one PCS change in laboratory assessments were reported. | From first dose of study drug up to last follow-up visit (up to 28 days) |
| Percentage of Participants With at Least One Potentially Clinically Significant Change in Electrocardiogram (ECG) Measurements | PCS changes for ECG measurements included: QTcF Interval >450 to ≤480 milliseconds (msec), >480 to ≤500 msec, and ≥30 to ≤60 msec increase from baseline. Percentage of participants with at least one PCS change in ECG measurements were reported. | From first dose of study drug up to last follow-up visit (up to 28 days) |
| Percentage of Participants With Suicidal Ideation or Behavior Assessed Using the Columbia Suicide Severity Rating Scale (C-SSRS) | The C-SSRS scale assesses the lifetime experience of participants with suicidal ideation (SI) and suicidal behavior (SB). The C-SSRS included "yes" or "no" responses for assessment of suicidal ideation and behavior as well as numeric ratings for the severity of ideation, if present (with score range from 1 to 5, with 5 being the most severe). The C-SSRS SI items involved wish to be dead, non-specific active suicidal thoughts, active SI with any methods, active SI with some intent and active SI with a specific plan. The C-SSRS SB items involved preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt (non-fatal) and completed suicide. Percentage of participants with a response of 'yes' for suicidal ideation or behavior were reported. | Up to Day 28 |
| Redlands |
| California |
| 92374 |
| United States |
| Sage Investigational Site | Miami | Florida | 33137 | United States |
| Sage Investigational Site | St. Petersburg | Florida | 33713 | United States |
| Sage Investigational Site | Decatur | Georgia | 30030 | United States |
| Sage Investigational Site | Decatur | Georgia | 30033 | United States |
| Sage Investigational Site | Gaithersburg | Maryland | 20877 | United States |
| Sage Investigational Site | Farmington Hills | Michigan | 48334 | United States |
| Sage Investigational Site | Omaha | Nebraska | 68130 | United States |
| Sage Investigational Site | North Canton | Ohio | 44720 | United States |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Safety Set included all participants who were administered investigational product (IP).
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | SAGE-718 | Participants received SAGE-718 3 mg oral tablets, once daily in the morning for 14 days. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| 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 Treatment-Emergent Adverse Events (TEAEs) | An adverse event (AE) was any untoward medical occurrence in a participant administered with a pharmaceutical product and that does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an IP whether or not related to the product. An AE can include any undesirable medical condition, even if no study treatment has been administered. TEAEs were defined as an AE with an onset date on or after the date of the first dose of IP or any worsening of a pre-existing medical condition/AE with onset after the start of IP and throughout the study. | Safety Set included all participants who were administered IP. | Posted | Count of Participants | Participants | From first dose of study drug up to last follow up visit (up to 28 days) |
|
|
| ||||||||||||||||||||||||||
| Secondary | Percentage of Participants With at Least One Potentially Clinically Significant (PCS) Change in Vital Signs Measurements | PCS changes for vital signs included: Supine Systolic Blood Pressure (SBP) >180 millimeters of mercury (mmHg), SBP decrease from baseline of ≥ 30 mmHg, standing 1-minute SBP >180 mmHg, standing 3 minutes SBP decrease from baseline of ≥ 30 mmHg, Supine diastolic BP (DBP) decrease from baseline of ≥ 20 mmHg, standing 1-minute DBP decrease from baseline of ≥ 20 mmHg, standing 1-minute DBP increase from baseline of ≥ 20 mmHg, standing 3-minute DBP increase from baseline of ≥ 20 mmHg, orthostatic SBP: supine-1 minute standing ≥ 20 mmHg and supine-3 minute standing ≥ 20 mmHg, orthostatic DBP: supine-1 minute standing ≥ 10 mmHg and supine-3 minute standing ≥ 10 mmHg. Percentage of participants with at least one PCS change in vital signs measurements were reported. | Safety Set included all participants who were administered IP. 'Overall number of participants analyzed' indicates the number of participants with data available for outcome measure analysis. | Posted | Number | percentage of participants | From first dose of study drug up to last follow-up visit (up to 28 days) |
|
| |||||||||||||||||||||||||||
| Secondary | Percentage of Participants With at Least One Potentially Clinically Significant Change in Laboratory Assessments | PCS changes for laboratory assessments included: hematology: hematocrit- male low (<0.385 fractions of 1), hemoglobin male low (<115 grams per liter [g/L]) and biochemistry: glucose high (>13.9 millimoles per liter [mmol/L]), potassium low (<3.3 mmol/L), blood urea nitrogen high (>10.71 mmol/L)., Percentage of participants with at least one PCS change in laboratory assessments were reported. | Safety Set included all participants who were administered IP. 'Overall number of participants analyzed' indicates the number of participants with data available for outcome measure analysis. | Posted | Number | percentage of participants | From first dose of study drug up to last follow-up visit (up to 28 days) |
|
| |||||||||||||||||||||||||||
| Secondary | Percentage of Participants With at Least One Potentially Clinically Significant Change in Electrocardiogram (ECG) Measurements | PCS changes for ECG measurements included: QTcF Interval >450 to ≤480 milliseconds (msec), >480 to ≤500 msec, and ≥30 to ≤60 msec increase from baseline. Percentage of participants with at least one PCS change in ECG measurements were reported. | Safety Set included all participants who were administered IP. 'Overall number of participants analyzed' indicates the number of participants with data available for outcome measure analysis. | Posted | Number | percentage of participants | From first dose of study drug up to last follow-up visit (up to 28 days) |
|
| |||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Suicidal Ideation or Behavior Assessed Using the Columbia Suicide Severity Rating Scale (C-SSRS) | The C-SSRS scale assesses the lifetime experience of participants with suicidal ideation (SI) and suicidal behavior (SB). The C-SSRS included "yes" or "no" responses for assessment of suicidal ideation and behavior as well as numeric ratings for the severity of ideation, if present (with score range from 1 to 5, with 5 being the most severe). The C-SSRS SI items involved wish to be dead, non-specific active suicidal thoughts, active SI with any methods, active SI with some intent and active SI with a specific plan. The C-SSRS SB items involved preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt (non-fatal) and completed suicide. Percentage of participants with a response of 'yes' for suicidal ideation or behavior were reported. | Safety Set included all participants who were administered IP. | Posted | Number | percentage of participants | Up to Day 28 |
|
|
Screening up to last follow-up visit (approximately 49 days)
Safety Set included all participants who were administered IP.
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 | SAGE-718 | Participants received SAGE-718 3 mg oral tablets, once daily in the morning for 14 days. | 0 | 26 | 0 | 26 | 7 | 26 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA version 23.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| Agitation | Psychiatric disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA version 23.1 | Systematic Assessment |
|
The PI can either be a party and subject to the same restrictions as the institution, or if not a party, the restrictions are described on the face of the contract (i.e., PI is a contractor of the institution; PI is part of a larger group of study personnel; institution has contracted with or otherwise bound all study personnel under confidentiality obligations and requirements to vest intellectual property to the institution).
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Monitor | Sage Therapeutics | (617) 299-8380 | info@sagerx.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 1, 2021 | Aug 30, 2024 | SAP_001.pdf |
| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| D060825 | Cognitive Dysfunction |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D024801 | Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D003072 | Cognition Disorders |
Not provided
Not provided
| Unknown or Not Reported |
|
| Other |
|
|
|
|
|
|