CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 72 enrolled
Drug / intervention
Cholinesterase inhibitor +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02248636
NCT02248636Phase 3Completed

Cholinesterase Inhibitor Discontinuation

VA Office of Research and Development·interventional·Posted Sep 25, 2014·Updated Oct 23, 2020

In Brief

A Phase 3 clinical trial evaluating Cholinesterase inhibitor and Sham discontinuation for Dementia. Completed, enrolled 72 participants across 4 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDementia
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
201520162017201820192020202120222023202420252026
First PostedSep 25, 2014
Enrollment StartJan 22, 2015
Primary CompletionOct 1, 2019
TodayJul 2, 2026
Enrollment to primary: 4.7 yearsPosted 11.8 years ago

Interventions

Cholinesterase inhibitordrug

This group receives a half-dose of their previous cholinesterase inhibitor medication (in overencapsulated form) for two weeks, then receives placebo.

Sham discontinuationdrug

This group receives their previous dose of cholinesterase inhibitor medication, but in overencapsulated form