A Study to Evaluate the Safety and Tolerability of SAGE-718 in Participants With Mild Cognitive Impairment or Mild Dementia Due to Alzheimer's Disease (AD)

• Sponsor: Sage Therapeutics (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04602624
• Collaborator: (none)
• Enrollment: 26
• Locations: 10
• Arm: 1
• Actual Duration (Months): 7.6
• Patients Per Site: 2.6
• Patients Per Site Per Month: 0.3

Study Details

Study Description

Brief Summary

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).

Condition or Disease	Intervention/Treatment	Phase
Alzheimer Disease; Cognitive Dysfunction; Mild Dementia	Drug: SAGE-718	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 26 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: An Open-Label Evaluation of the Safety and Tolerability of SAGE-718 in Participants With Mild Cognitive Impairment or Mild Dementia Due to Alzheimer's Disease
• Actual Study Start Date: Feb 2, 2021
• Actual Primary Completion Date: Sep 21, 2021
• Actual Study Completion Date: Sep 21, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: SAGE-718 Participants will receive a single dose of SAGE-718 oral tablets, once daily in the morning for 14 days.	Drug: SAGE-718; SAGE-718 oral tablets.

Outcome Measures

Primary Outcome Measures

1. Number of Participants With Treatment-Emergent Adverse Events (TEAE) [Up to Day 28]

   An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment. A TEAE is an AE that occurs after the first administration of a study drug.

Secondary Outcome Measures

1. Percentage of Participants With Clinically Significant Changes in Vital Signs Measurements [Up to Day 28]

2. Percentage of Participants With Clinically Significant Changes in Laboratory Assessments [Up to Day 28]

3. Percentage of Participants With Clinically Significant Changes in Electrocardiogram (ECG) Measurements [Up to Day 28]

4. Percentage of Participants With Change From Baseline Responses on the Columbia Suicide Severity Rating Scale (C-SSRS) [Up to Day 28]

   The C-SSRS scale consists of a baseline evaluation that assesses the lifetime experience of participants with suicidal ideation (SI) and suicidal behavior (SB) and a postbaseline evaluation that focuses on suicidality since the last study visit. The C-SSRS includes 'yes' or 'no' responses for assessment of suicidal ideation and behavior as well as numeric ratings for severity of ideation, if present (from 1 to 5, with 5 being the most severe).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 50 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Participant meets the following criteria for MCI or mild dementia due to AD at Screening: has a memory complaint, has clinical dementia rating (CDR) score of 0.5 to 1.0 (inclusive) with a memory box score ≥0.5, has essentially preserved activities of daily living

2. Participant has a score of 15 to 24 (inclusive) on the Montreal Cognitive Assessment at Screening

3. Participant has normal premorbid intelligence quotient (IQ) at Screening

4. Participant has a study partner who is reliable, competent, at least 18 years of age, willing to be available to the study center by phone, support study-specific activities, and accompany the participant to study visits as needed

Exclusion Criteria:

1. Participant has any medical or neurological condition (other than AD) that might be contributing to the participant's cognitive impairment or history of cognitive decline

2. Participant has a history of brain surgery, deep brain stimulation, a significant head injury causing loss of consciousness greater than 30 minutes, or hospitalization due to a brain injury

3. Participant has a history, presence, and/or current evidence of a clinically-significant intracranial abnormality (eg, stroke, hemorrhage, space-occupying lesion) that could account for the observed cognitive impairment (excluding abnormalities consistent with underlying AD pathology)

4. Participant has a history of possible or probable cerebral amyloid angiopathy, according to the Boston Criteria

5. Participant has a history of seizures or epilepsy, with the exception of a single episode of febrile seizures in childhood

6. Participant has current or recent suicidality

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sage Investigational Site	Phoenix	Arizona	United States	85044
2	Sage Investigational Site	Redlands	California	United States	92374
3	Sage Investigational Site	Miami	Florida	United States	33137
4	Sage Investigational Site	Saint Petersburg	Florida	United States	33713
5	Sage Investigational Site	Decatur	Georgia	United States	30030
6	Sage Investigational Site	Decatur	Georgia	United States	30033
7	Sage Investigational Site	Gaithersburg	Maryland	United States	20877
8	Sage Investigational Site	Farmington Hills	Michigan	United States	48334
9	Sage Investigational Site	Omaha	Nebraska	United States	68130
10	Sage Investigational Site	North Canton	Ohio	United States	44720

Sponsors and Collaborators

• Sage Therapeutics

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Sage Therapeutics
• ClinicalTrials.gov Identifier: NCT04602624
• Other Study ID Numbers: 718-CNA-201
• First Posted: Oct 26, 2020
• Last Update Posted: Jan 21, 2022
• Last Verified: Jan 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Alzheimer Disease; Dementia; Cognitive Dysfunction

Study Results

No Results Posted as of Jan 21, 2022