An Open-Label Evaluation of the Safety and Tolerability of SAGE-718 in Participants with Parkinson’s Disease Mild Cognitive Impairment

  • STATUS
    Recruiting
  • sponsor
    Sage
Updated on 29 July 2021
cognitive impairment
dementia
mild cognitive impairment

Summary

Mild cognitive impairment is a condition that is associated with decreased quality of life, impaired functioning, and is common in people who have Parkinson’s Disease (PD). People with Parkinson’s Disease mild cognitive impairment (PD-MCI) are at a high risk for developing dementia.

Your participation in this study will last approximately 7 weeks, including a maximum 2-week screening period, a 1-week baseline period, a 2-week study treatment period, and a 2-week follow up period. During this time, you will visit the clinic for study assessments and procedures a total of 7 times.

Description

  • This is an open-label study.
  • Open-label: in an open-label study, both the study doctor(s) and the study subject know the study treatment the study subject is receiving

Details
Condition Alzheimer's Disease, Memory Loss, Memory Problems
Clinical Study IdentifierTX278583
SponsorSage
Last Modified on29 July 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Eligible participants must meet the following criteria
Be between the ages of 50 and 75, inclusive Have a confirmed diagnosis of PD-MCI
Be able to walk and able to travel to the study center
Cane use is acceptable; individuals requiring a walker or wheelchair are not eligible
Have a study partner who is reliable, competent, at least 18 years of age, and willing to be available to the study center by phone
Additional criteria will be assessed by the study team
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What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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