Cholinesterase Inhibitor Discontinuation

Completed · Phase 2/Phase 3 · Has a placebo group

Conditions studied: Dementia

In brief

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.

Key facts

Study ID

NCT02248636

Run by

VA Office of Research and Development

People needed

72

Starts

2015-01-22

Expected to finish

2019-10-01

Last updated by the study team

2020-10-23

Who can join

Age: 60 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Central Arkansas VHS John L. McClellan Memorial Veterans Hospital, Little Rock, AR — Little Rock, Arkansas, United States
• Boise VA Medical Center, Boise, ID — Boise, Idaho, United States
• Edith Nourse Rogers Memorial Veterans Hospital, Bedford, MA — Bedford, Massachusetts, United States
• VA Puget Sound Health Care System Seattle Division, Seattle, WA — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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