Trial Outcomes & Findings for A Study to Evaluate the Safety and Tolerability of SAGE-718 in Participants With Parkinson's Disease Mild Cognitive Impairment (PD-MCI) (NCT NCT04476017)
NCT ID: NCT04476017
Last Updated: 2025-09-15
Results Overview
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 this 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. Percentages are rounded off to the nearest single decimal.
COMPLETED
PHASE2
18 participants
From first dose of study drug up to 28 days
2025-09-15
Participant Flow
Participants were enrolled in the study at 4 investigative sites in the United States and took part in the study that ran from 31 July 2020 to 25 March 2022.
Participant milestones
| Measure |
Part A: SAGE-718 3 mg
Participants received SAGE-718 3 milligrams (mg) tablets, once daily with food in the morning for 14 days in Part A of study.
|
Part B: SAGE-718 3 mg
Participants received SAGE-718 3 mg tablets, once daily with food in the morning for 28 days in Part B of study.
|
|---|---|---|
|
Part A (28 Days)
STARTED
|
11
|
0
|
|
Part A (28 Days)
COMPLETED
|
10
|
0
|
|
Part A (28 Days)
NOT COMPLETED
|
1
|
0
|
|
Part B (42 Days)
STARTED
|
0
|
7
|
|
Part B (42 Days)
COMPLETED
|
0
|
7
|
|
Part B (42 Days)
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
Part A: SAGE-718 3 mg
Participants received SAGE-718 3 milligrams (mg) tablets, once daily with food in the morning for 14 days in Part A of study.
|
Part B: SAGE-718 3 mg
Participants received SAGE-718 3 mg tablets, once daily with food in the morning for 28 days in Part B of study.
|
|---|---|---|
|
Part A (28 Days)
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
A Study to Evaluate the Safety and Tolerability of SAGE-718 in Participants With Parkinson's Disease Mild Cognitive Impairment (PD-MCI)
Baseline characteristics by cohort
| Measure |
Part A: SAGE-718 3 mg
n=11 Participants
Participants received SAGE-718 3 mg tablets, once daily with food in the morning for 14 days in Part A of study.
|
Part B: SAGE-718 3 mg
n=7 Participants
Participants received SAGE-718 3 mg tablets, once daily with food in the morning for 28 days in Part B of study.
|
Total
n=18 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
69.1 years
n=5 Participants
|
70.3 years
n=7 Participants
|
69.6 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
11 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
11 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From first dose of study drug up to 28 daysPopulation: Safety Set included all participants who were administered IP.
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 this 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. Percentages are rounded off to the nearest single decimal.
Outcome measures
| Measure |
Part A: SAGE-718 3 mg
n=11 Participants
Participants received SAGE-718 3 mg tablets, once daily with food in the morning for 14 days in Part A of study.
|
Part B: SAGE-718 3 mg
Participants received SAGE-718 3 mg tablets, once daily with food in the morning for 28 days in Part B of study.
|
|---|---|---|
|
Part A: Percentage of Participants With at Least One Treatment-Emergent Adverse Event (TEAE)
|
45.5 percentage of participants
|
—
|
PRIMARY outcome
Timeframe: From first dose of study drug up to 42 daysPopulation: Safety Set included all participants who were administered IP.
An AE was any untoward medical occurrence in a participant administered with a pharmaceutical product and that does not necessarily have a causal relationship with this 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. Percentages are rounded off to the nearest single decimal.
Outcome measures
| Measure |
Part A: SAGE-718 3 mg
n=7 Participants
Participants received SAGE-718 3 mg tablets, once daily with food in the morning for 14 days in Part A of study.
|
Part B: SAGE-718 3 mg
Participants received SAGE-718 3 mg tablets, once daily with food in the morning for 28 days in Part B of study.
|
|---|---|---|
|
Part B: Percentage of Participants With at Least One Treatment-Emergent Adverse Event (TEAE)
|
14.3 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: From first dose of study drug up to 28 days for Part A, and up to 42 days for Part BPopulation: Safety Set included all participants who were administered IP.
Vital signs included temperature, respiratory rate, heart rate (supine and standing), systolic blood pressure (supine and standing) and diastolic blood pressure (supine and standing). Percentage of participants with clinically significant change in vital signs measurements which were deemed clinically significant by the investigator were reported.
Outcome measures
| Measure |
Part A: SAGE-718 3 mg
n=11 Participants
Participants received SAGE-718 3 mg tablets, once daily with food in the morning for 14 days in Part A of study.
|
Part B: SAGE-718 3 mg
n=7 Participants
Participants received SAGE-718 3 mg tablets, once daily with food in the morning for 28 days in Part B of study.
|
|---|---|---|
|
Part A and B: Percentage of Participants With Clinically Significant Changes in Vital Sign Measurements
|
0 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: From first dose of study drug up to 28 days for Part A, and up to 42 days for Part BPopulation: Safety Set included all participants who were administered IP.
Laboratory tests assessments included hematology, biochemistry, coagulation and urinalysis. Percentage of participants with clinically significant change in laboratory assessments which were deemed clinically significant by the investigator were reported.
Outcome measures
| Measure |
Part A: SAGE-718 3 mg
n=11 Participants
Participants received SAGE-718 3 mg tablets, once daily with food in the morning for 14 days in Part A of study.
|
Part B: SAGE-718 3 mg
n=7 Participants
Participants received SAGE-718 3 mg tablets, once daily with food in the morning for 28 days in Part B of study.
|
|---|---|---|
|
Part A and B: Percentage of Participants With Clinically Significant Changes in Laboratory Assessments
|
0 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: From first dose of study drug up to 28 days for Part A, and up to 42 days for Part BPopulation: Safety Set included all participants who were administered IP.
Supine 12-lead ECGs were performed in triplicate and the standard intervals (heart rate, PR interval, QRS duration, QT interval, and corrected QT interval by Fridericia \[QTcF\]). Percentage of participants with clinically significant change in ECG measurements which were deemed clinically significant by the investigator were reported.
Outcome measures
| Measure |
Part A: SAGE-718 3 mg
n=11 Participants
Participants received SAGE-718 3 mg tablets, once daily with food in the morning for 14 days in Part A of study.
|
Part B: SAGE-718 3 mg
n=7 Participants
Participants received SAGE-718 3 mg tablets, once daily with food in the morning for 28 days in Part B of study.
|
|---|---|---|
|
Part A and B: Percentage of Participants With Clinically Significant Changes in Electrocardiogram (ECG) Measurements
|
0 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: From first dose of study drug up to 28 days for Part A, and up to 42 days for Part BPopulation: Safety Set included all participants who were administered IP.
The C-SSRS scale consisted of a baseline evaluation (at screening) that assessed the lifetime experience of participants with suicidal ideation (SI) and suicidal behavior (SB) and a postbaseline evaluation that focused on suicidality since the last study visit. 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 (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' are reported for both suicidal ideation and behavior in this OM.
Outcome measures
| Measure |
Part A: SAGE-718 3 mg
n=11 Participants
Participants received SAGE-718 3 mg tablets, once daily with food in the morning for 14 days in Part A of study.
|
Part B: SAGE-718 3 mg
n=7 Participants
Participants received SAGE-718 3 mg tablets, once daily with food in the morning for 28 days in Part B of study.
|
|---|---|---|
|
Part A and B: Percentage of Participants With a Response of 'Yes' to Any Suicidal Ideation or Suicidal Behaviors Item Assessed Using the Columbia Suicide Severity Rating Scale (C-SSRS)
Suicidal Ideation
|
0 percentage of participants
|
0 percentage of participants
|
|
Part A and B: Percentage of Participants With a Response of 'Yes' to Any Suicidal Ideation or Suicidal Behaviors Item Assessed Using the Columbia Suicide Severity Rating Scale (C-SSRS)
Suicidal Behavior
|
0 percentage of participants
|
0 percentage of participants
|
Adverse Events
Part A: SAGE-718 3 mg
Part B: SAGE-718 3 mg
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Part A: SAGE-718 3 mg
n=11 participants at risk
Participants received SAGE-718 3 mg tablets, once daily with food in the morning for 14 days in Part A of study.
|
Part B: SAGE-718 3 mg
n=7 participants at risk
Participants received SAGE-718 3 mg tablets, once daily with food in the morning for 28 days in Part B of study.
|
|---|---|---|
|
Gastrointestinal disorders
Large intestine polyp
|
9.1%
1/11 • From first dose of study drug up to 28 days for Part A, and up to 42 days for Part B
Safety Set included all participants who were administered IP.
|
0.00%
0/7 • From first dose of study drug up to 28 days for Part A, and up to 42 days for Part B
Safety Set included all participants who were administered IP.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/11 • From first dose of study drug up to 28 days for Part A, and up to 42 days for Part B
Safety Set included all participants who were administered IP.
|
14.3%
1/7 • From first dose of study drug up to 28 days for Part A, and up to 42 days for Part B
Safety Set included all participants who were administered IP.
|
|
General disorders
Asthenia
|
9.1%
1/11 • From first dose of study drug up to 28 days for Part A, and up to 42 days for Part B
Safety Set included all participants who were administered IP.
|
0.00%
0/7 • From first dose of study drug up to 28 days for Part A, and up to 42 days for Part B
Safety Set included all participants who were administered IP.
|
|
General disorders
Fatigue
|
0.00%
0/11 • From first dose of study drug up to 28 days for Part A, and up to 42 days for Part B
Safety Set included all participants who were administered IP.
|
14.3%
1/7 • From first dose of study drug up to 28 days for Part A, and up to 42 days for Part B
Safety Set included all participants who were administered IP.
|
|
Infections and infestations
Urinary tract infection
|
9.1%
1/11 • From first dose of study drug up to 28 days for Part A, and up to 42 days for Part B
Safety Set included all participants who were administered IP.
|
0.00%
0/7 • From first dose of study drug up to 28 days for Part A, and up to 42 days for Part B
Safety Set included all participants who were administered IP.
|
|
Injury, poisoning and procedural complications
Eye contusions
|
9.1%
1/11 • From first dose of study drug up to 28 days for Part A, and up to 42 days for Part B
Safety Set included all participants who were administered IP.
|
0.00%
0/7 • From first dose of study drug up to 28 days for Part A, and up to 42 days for Part B
Safety Set included all participants who were administered IP.
|
|
Injury, poisoning and procedural complications
Fall
|
9.1%
1/11 • From first dose of study drug up to 28 days for Part A, and up to 42 days for Part B
Safety Set included all participants who were administered IP.
|
0.00%
0/7 • From first dose of study drug up to 28 days for Part A, and up to 42 days for Part B
Safety Set included all participants who were administered IP.
|
|
Injury, poisoning and procedural complications
Skin laceration
|
9.1%
1/11 • From first dose of study drug up to 28 days for Part A, and up to 42 days for Part B
Safety Set included all participants who were administered IP.
|
0.00%
0/7 • From first dose of study drug up to 28 days for Part A, and up to 42 days for Part B
Safety Set included all participants who were administered IP.
|
|
Investigations
Activated partial thromboplastin time prolonged
|
9.1%
1/11 • From first dose of study drug up to 28 days for Part A, and up to 42 days for Part B
Safety Set included all participants who were administered IP.
|
0.00%
0/7 • From first dose of study drug up to 28 days for Part A, and up to 42 days for Part B
Safety Set included all participants who were administered IP.
|
|
Investigations
International normalized ratio increased
|
9.1%
1/11 • From first dose of study drug up to 28 days for Part A, and up to 42 days for Part B
Safety Set included all participants who were administered IP.
|
0.00%
0/7 • From first dose of study drug up to 28 days for Part A, and up to 42 days for Part B
Safety Set included all participants who were administered IP.
|
|
Renal and urinary disorders
Leukocyturia
|
9.1%
1/11 • From first dose of study drug up to 28 days for Part A, and up to 42 days for Part B
Safety Set included all participants who were administered IP.
|
0.00%
0/7 • From first dose of study drug up to 28 days for Part A, and up to 42 days for Part B
Safety Set included all participants who were administered IP.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/11 • From first dose of study drug up to 28 days for Part A, and up to 42 days for Part B
Safety Set included all participants who were administered IP.
|
14.3%
1/7 • From first dose of study drug up to 28 days for Part A, and up to 42 days for Part B
Safety Set included all participants who were administered IP.
|
|
Nervous system disorders
Parkinsonism
|
0.00%
0/11 • From first dose of study drug up to 28 days for Part A, and up to 42 days for Part B
Safety Set included all participants who were administered IP.
|
14.3%
1/7 • From first dose of study drug up to 28 days for Part A, and up to 42 days for Part B
Safety Set included all participants who were administered IP.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/11 • From first dose of study drug up to 28 days for Part A, and up to 42 days for Part B
Safety Set included all participants who were administered IP.
|
14.3%
1/7 • From first dose of study drug up to 28 days for Part A, and up to 42 days for Part B
Safety Set included all participants who were administered IP.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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).
- Publication restrictions are in place
Restriction type: OTHER