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)

Alzheimer Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04602624
• Other study ID #: 718-CNA-201
• Status: Completed
• Phase: Phase 2
• Start date: February 2, 2021
• Est. completion date: September 21, 2021

Study information

• Verified date: September 2022
• Source: Sage Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: September 21, 2021
• Est. primary completion date: September 21, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Alzheimer Disease
• Cognitive Dysfunction
• Dementia
• Mild Dementia

Intervention

Drug:
• SAGE-718
SAGE-718 oral tablets.

Locations

Country	Name	City	State
United States	Sage Investigational Site	Decatur	Georgia
United States	Sage Investigational Site	Decatur	Georgia
United States	Sage Investigational Site	Farmington Hills	Michigan
United States	Sage Investigational Site	Gaithersburg	Maryland
United States	Sage Investigational Site	Miami	Florida
United States	Sage Investigational Site	North Canton	Ohio
United States	Sage Investigational Site	Omaha	Nebraska
United States	Sage Investigational Site	Phoenix	Arizona
United States	Sage Investigational Site	Redlands	California
United States	Sage Investigational Site	Saint Petersburg	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Sage Therapeutics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Treatment-Emergent Adverse Events (TEAE)	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.	Up to Day 28
Secondary	Percentage of Participants With Clinically Significant Changes in Vital Signs Measurements		Up to Day 28
Secondary	Percentage of Participants With Clinically Significant Changes in Laboratory Assessments		Up to Day 28
Secondary	Percentage of Participants With Clinically Significant Changes in Electrocardiogram (ECG) Measurements		Up to Day 28
Secondary	Percentage of Participants With Change From Baseline Responses on the Columbia Suicide Severity Rating Scale (C-SSRS)	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).	Up to Day 28