drugset / Trial / NCT02248636

Cholinesterase Inhibitor Discontinuation

NCT02248636

Phase 2/3 Completed 72 enrolled VA Office of Research and Development
RandomizedSingle-groupQuadruple-blindTreatment

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.

Timeline

Start
2015-01-22
Primary completion
2019-10-01
Completion
2019-10-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Donepezil Small molecule
Subject Galantamine Small molecule

Indications