Overview
Cholinesterase Inhibitor Discontinuation
Status:
Completed
Completed
Trial end date:
2019-10-01
2019-10-01
Target enrollment:
0
0
Participant gender:
All
All
Summary
This study tries to determine if stopping certain medications that are used to treat dementia will cause worsening from the patient and family perspective. All of the participants will take pills that look identical, and that may contain active drug or an inactive pill (a placebo). Half of the group will receive the same treatment they were taking before the study -- this is called the "sham discontinuation" arm. The other half will receive a reduced dose of their medication, and then an inactive pill (placebo) -- this is called the "real discontinuation" arm. Participants will be able to return to their previous dose of medication at any time during the study. The percentage of people who return will be measured and compared. Other medical events and factors such as behaviors, thinking, and caregiver distress, will be measured and compared between the groups.Phase:
Phase 2/Phase 3Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
VA Office of Research and DevelopmentTreatments:
Cholinesterase Inhibitors
Criteria
Inclusion Criteria:- Males and females ages 60 and older.
- Taking stable dose of donepezil 10mg or greater per day, or galantamine 8mg or greater
per day, for at least 1 year.
- Presence of a primary caregiver who can assume responsibility for medication
compliance, OR residence in a nursing home with a staff member who can provide
information.
- Primary care visit within last 12 months.
- Willing to have the CI medication discontinued.
Exclusion Criteria:
- Terminal medical condition for which life expectancy would be less than 6 months.
- Parkinson's Disease
- Presence of any uncontrolled systemic illness that would interfere with participation
in the study.
- Unstable medical condition.
- Receiving services from hospice.
- Current prescription with more than one CI
- Receiving medication in an investigational drug study.