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SAGE-718 for Alzheimer's Disease

Phase 2
Recruiting
Research Sponsored by Sage Therapeutics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from the inform consent signing up to end of the study (up to approximately day 119)
Awards & highlights

Study Summary

This trial tests if a new drug can improve thinking skills in people with Alzheimer's Disease.

Who is the study for?
This trial is for adults with mild cognitive impairment or mild dementia due to Alzheimer's Disease, who can still manage daily activities and have a specific score range on the MoCA test. They must not have other medical conditions that could explain their cognitive issues, nor should they be pregnant, breastfeeding, allergic to SAGE-718 ingredients like soy lecithin, or have certain neurological histories.Check my eligibility
What is being tested?
The study tests the effects of SAGE-718 on cognitive performance in Alzheimer's patients compared to a placebo. Participants will either receive SAGE-718 or a matching dummy pill without active medication (placebo) to assess any differences in mental function outcomes.See study design
What are the potential side effects?
While specific side effects are not listed here, participants may experience reactions related to the components of SAGE-718. Allergic responses could occur in those sensitive to its ingredients such as soy lecithin.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from the inform consent signing up to end of the study (up to approximately day 119)
This trial's timeline: 3 weeks for screening, Varies for treatment, and from the inform consent signing up to end of the study (up to approximately day 119) 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 in the Wechsler Adult Intelligence Scale Fourth Edition-IV (WAIS-IV) Coding Test
Secondary outcome measures
Number of Participants Who Withdraw Due to Adverse Events (AEs)
Percentage of Participants With At least One or More Treatment-emergent Adverse Events (TEAEs) and 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 1.2mg of SAGE-718 orally once daily for the first 6 weeks Days 1 to 42 [±2 days], followed by 0.9 mg of SAGE-718 for the remainder of the Treatment period up to Day 84 Visit [±7 days].
Group II: PlaceboPlacebo Group1 Intervention
Participants will receive placebo-matching capsule once daily orally throughout the treatment period for up to Day 84.
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
11,611 Total Patients Enrolled

Media Library

SAGE-718 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05619692 — Phase 2
Mild Cognitive Impairment Research Study Groups: SAGE-718, Placebo
Mild Cognitive Impairment Clinical Trial 2023: SAGE-718 Highlights & Side Effects. Trial Name: NCT05619692 — Phase 2
SAGE-718 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05619692 — Phase 2
Mild Cognitive Impairment Patient Testimony for trial: Trial Name: NCT05619692 — Phase 2

Frequently Asked Questions

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

Is this examination currently enrolling participants?

"As per information provided by clinicaltrials.gov, this medical trial is enlisting participants as of now. The study was initially posted on December 27th 2022 and recently modified on January 13th 2023."

Answered by AI

Does this trial encompass the geriatric population?

"The prerequisites for this trial demand that applicants be between the ages of 50 to 80. To contrast, there are 48 trials available for those under 18 and 1083 studies recruiting patients above 65 years old."

Answered by AI

Is SAGE-718 an innocuous treatment for humans?

"Considering the fact that SAGE-718 is being tested in a Phase 2 trial, with evidence of safety but not efficacy yet, it has been given a rating of 2."

Answered by AI

What is the maximum enrollment for this experimental research?

"Correct. The clinicaltrials.gov database demonstrates that this medical investigation, initially made available on December 27th 2022, is actively recruiting participants. A total of 150 individuals must be recruited from 4 centres throughout the country."

Answered by AI

How many locations are currently executing this experiment within the city limits?

"Currently, 4 facilities across the nation are running this clinical trial. Specifically located in Sherman Oaks, Decatur, and Brooklyn; with one additional location yet to be revealed. To reduce any potential travel-related hassles participants may face, it is highly recommended that they select a site close by their locality."

Answered by AI

Who can gain admittance to this research project?

"This clinical trial seeks 150 adults with mild cognitive impairment in the age range of 50 to 80. To qualify, participants must exhibit a memory complaint as reported by themselves or their study partner, have a CDR score between 0.5 and 1.0 (inclusive) with a memory box score ≥0.5, be able to maintain activities of daily living reliably, possess an MRI report that confirms Alzheimer's disease but does not demonstrate non-Alzheimer pathologies causing the observed deficits, and earn 15 to 25 points on the Montreal Cognitive Assessment at Screening."

Answered by AI

Who else is applying?

What state do they live in?
California
What site did they apply to?
Sage Investigational Site
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
2
1

What questions have other patients asked about this trial?

How long is the screening process and what is involved in this process ... and when does the trial start and end?
PatientReceived no prior treatments

Why did patients apply to this trial?

I would to avert, or at munimu. Have amyloid plaque conformation. I would like to be part of the cure for Altziemers.
PatientReceived 1 prior treatment
I'm tired of missing important dates, events, taking meds, losing thing, forgetting where I parked, and the list go's on.
PatientReceived 2+ prior treatments
Recent research and studies
clinicaltrials.govStudy
A Study to Evaluate the Effects of SAGE-718 in Participants With Mild Cognitive Impairment or Mild Dementia Due to Alzheimer's Disease (AD)
2022. "A Study to Evaluate the Effects of SAGE-718 in Participants With Mild Cognitive Impairment or Mild Dementia Due to Alzheimer's Disease (AD)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05619692.
All > Alzheimers Disease Dallas > Mild Cognitive Impairment
~46 spots leftby Dec 2024
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