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SAGE-718 for Parkinson's Disease Cognitive Impairment

Phase 2
Waitlist Available
Research Sponsored by Sage Therapeutics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Meet the following criteria for PD-MCI: Have a confirmed diagnosis of idiopathic Parkinson's disease (PD) according to 2015 Movement Disorder Society (MDS) clinical diagnostic criteria and meet MDS Task Force criteria for MCI in PD (excluding requirement for United Kingdom PD Brain Bank diagnostic criteria)
Meet criteria for modified Hoehn & Yahr Stage I to III (mild to moderate motor severity) at Screening
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to day 70
Awards & highlights

Study Summary

This trial will test if SAGE-718 can improve cognitive performance in people with Parkinson's disease and mild cognitive impairment.

Who is the study for?
This trial is for people with Parkinson's disease who have mild to moderate motor symptoms and some cognitive impairment, but no dementia or significant psychotic symptoms. They should be able to perform certain cognitive tests and have had stable motor symptoms for at least 4 weeks.Check my eligibility
What is being tested?
The study is testing SAGE-718 against a placebo to see if it improves thinking abilities in those with Parkinson's-related mild cognitive issues. Participants will randomly receive either the actual drug or a fake pill that looks the same.See study design
What are the potential side effects?
While specific side effects of SAGE-718 are not detailed here, common side effects from drugs targeting brain function may include nausea, headache, dizziness, fatigue, and sometimes mood changes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have Parkinson's disease with mild cognitive impairment as diagnosed by specific criteria.
Select...
My Parkinson's disease is in the mild to moderate stage.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to day 70
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to day 70 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change from Baseline to Day 42 in the Wechsler Adult Intelligence Scale-IV (WAIS-IV) Coding Test Score
Secondary outcome measures
Number of Participants who Withdraw Due to Adverse Events (AEs)
Percentage of Participants with at Least One Treatment-Emergent Adverse Event (TEAE) and TEAEs by Severity

Side effects data

From 2022 Phase 2 trial • 18 Patients • NCT04476017
9%
Activated partial thromboplastin time prolonged
9%
International normalized ratio increased
9%
Leukocyturia
9%
Skin laceration
9%
Large intestine polyp
9%
Asthenia
9%
Urinary tract infection
9%
Eye contusions
9%
Fall
100%
80%
60%
40%
20%
0%
Study treatment Arm
Part A: SAGE-718 3 mg
Part B: SAGE-718 3 mg

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: SAGE-718Experimental Treatment1 Intervention
Participants will receive SAGE-718 capsules, orally, once daily in the morning for 42 days.
Group II: PlaceboPlacebo Group1 Intervention
Participants will receive SAGE-718-matching placebo capsules, orally, once daily in the morning for 42 days.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
SAGE-718
2020
Completed Phase 2
~220

Find a Location

Who is running the clinical trial?

Sage TherapeuticsLead Sponsor
49 Previous Clinical Trials
11,675 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants are being enrolled in this experiment?

"Affirmative. Clinicaltrials.gov states that this investigation, which was originally posted on July 6th 2022, is still in need of participants. 76 volunteers must be found between 7 different medical institutions."

Answered by AI

What possible risks accompany the use of SAGE-718?

"Taking safety into consideration, SAGE-718 received a rating of 2 on our scale. This is due to its Phase 2 status, suggesting that while it has provided evidence for its security there are no studies proving its efficacy yet."

Answered by AI

Is the age restriction for this research study limited to those under fifty years of age?

"As per the trial's requirements, only individuals aged between 50 and 75 are allowed to take part in this investigation."

Answered by AI

Are there any open vacancies in this experiment for participants?

"Affirmative. Clinicaltrials.gov reports that this study, first posted on June 7th 2022, is actively seeking patients for participation. 76 people are required from seven different sites in order to complete the research."

Answered by AI

How widespread is the implementation of this trial within US medical institutions?

"Currently, the trial is running in 7 distinct medical centres. These are located in Decatur, Port Orange and Virginia Beach as well as 4 additional areas. To limit transportation needs for participants, it is important to select a site that is within close proximity of their residence."

Answered by AI

Who qualifies to participate in this medical study?

"This investigation is recruiting 76 participants between 50 and 75 years old who present with cognitive decline. To be eligible, they must meet Movement Disorder Society's 2015 criteria for idiopathic Parkinson's disease; satisfy the requirements of Mild cognitive impairment in PD (barring UK Brain Bank Diagnosis); have a Montreal Cognitive Assessment score ranging from 20 to 25 if meeting Level 1 PD-MCI Criteria; fall into Hoehn & Yahr Stages I to III for mild to moderate motor severity; receive an MoCA score of 18-25 if within last year and having stable symptoms at least 4 weeks prior to screening."

Answered by AI

Who else is applying?

What site did they apply to?
Sage Investigational Site
What portion of applicants met pre-screening criteria?
Did not meet criteria

Why did patients apply to this trial?

I want to support the PD community and have been a part of other non-pharmaceiutical clinical trials.
PatientReceived no prior treatments
Recent research and studies
clinicaltrials.govStudy
A Study to Evaluate the Effects of SAGE-718 in Participants With Parkinson's Disease Cognitive Impairment
2022. "A Study to Evaluate the Effects of SAGE-718 in Participants With Parkinson's Disease Cognitive Impairment". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05318937.
~31 spots leftby Apr 2025
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