Trial · NCT02248636

Cholinesterase Inhibitor Discontinuation

NCT02248636, Phase 2, Phase 3, Completed, VA Office of Research and Development; results first posted 2020-10-23

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Cholinesterase Inhibitor Discontinuation. Trials, record NCT02248636. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02248636

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Cholinesterase Inhibitor Discontinuation
NCT number: NCT02248636
Status: Completed
Phases: Phase 2, Phase 3
Enrollment: 72 participants, actual
Lead sponsor: VA Office of Research and Development
Conditions: Dementia
Interventions: Cholinesterase inhibitor, Sham discontinuation
First posted: 2014-09-25
Last updated: 2020-10-23
Results first posted: 2020-10-23
Limitations and caveats: The study was designed to allow participants to stop the study medication at any time, and for any reason. This is different than administrative withdrawal.

Source ClinicalTrials.gov

Registered outcomes6

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Successful Completion	6 weeks	Participants can return to their pre-study dose of medication at any time. If they complete 6 weeks of either real discontinuation or sham discontinuation, they are considered to have successfully completed treatment.
Secondary	Caregiver Burden	6 weeks	The Zarit Caregiver Burden Interview contains 22 items, each on a 5-point scale, for a maximum score of 110. The minimum score is 0. A higher score indicates worse subjective burden.
Secondary	Veteran Cognition	6 weeks	Six-Item Screener is a telephone-based assessment of cognitive status. The score ranges from 0 to 6. A higher score indicates better cognition.
Secondary	Veteran Functioning	6 weeks	The Alzheimer's Disease Cooperative Study ADL Scale (ADCS-ADL) is a 23-item scale divided into activities of daily living and independent activities of daily living. Scores range from 0-78. A lower score indicates worse functional ability.
Secondary	Behavioral Symptoms	6 weeks	The Behavioral Pathology in Alzheimer's Disease Rating Scale (BEHAVE-AD) is a 25-item instrument. Scores range from 0-75, with a higher number indicating worse behavioral symptoms.
Secondary	Post-study Treatment Choice	12 weeks	Veteran and caregiver decision to continue, or to have restarted, the pre-study medication at 12 weeks. The participants were unblinded at 6 weeks, and were requested to make their own decision about restarting.

Source ClinicalTrials.gov

Outcomes6

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Successful Completion	6 weeks		Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Caregiver Burden	6 weeks	Not all of the caregivers completed the instrument. Some were unavailable after study enrollment. Some had a change in caregiver. Some refused to respond to all of the questions, since the instrument is rather lengthy.	Change in Zarit score	MEAN
SECONDARY	Veteran Cognition	6 weeks	Some of the participants refused to complete the cognitive instrument over the phone.	Change in Six-Item Screener Score	MEAN
SECONDARY	Veteran Functioning	6 weeks		score on a scale	MEAN
SECONDARY	Behavioral Symptoms	6 weeks	Not all caregivers were willing to respond to all the items.	score on a scale	MEAN
SECONDARY	Post-study Treatment Choice	12 weeks	We were unable to reach some participants at 12 weeks.	Participants	COUNT_OF_PARTICIPANTS

Source ClinicalTrials.gov

Results by group14

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Successful Completion	Real Discontinuation	20		Participants
Successful Completion	Sham Discontinuation	32		Participants
Caregiver Burden	Real Discontinuation	5.58	Standard Deviation 11.13	Change in Zarit score
Caregiver Burden	Sham Discontinuation	1.66	Standard Deviation 17.56	Change in Zarit score
Veteran Cognition	Real Discontinuation	-0.15	Standard Deviation 2.13	Change in Six-Item Screener Score
Veteran Cognition	Sham Discontinuation	0.13	Standard Deviation 0.90	Change in Six-Item Screener Score
Veteran Functioning	Real Discontinuation	-1.44	Standard Deviation 11.87	score on a scale
Veteran Functioning	Sham Discontinuation	-0.59	Standard Deviation 6.72	score on a scale
Behavioral Symptoms	Real Discontinuation	-1.63	Standard Deviation 6.26	score on a scale
Behavioral Symptoms	Sham Discontinuation	-1.23	Standard Deviation 3.79	score on a scale

1 to 10 of 14Source ClinicalTrials.gov

See all 14 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Real Discontinuation	26
Overall Study	STARTED	Sham Discontinuation	35
Overall Study	COMPLETED	Real Discontinuation	20
Overall Study	COMPLETED	Sham Discontinuation	32
Overall Study	NOT COMPLETED	Real Discontinuation	6
Overall Study	NOT COMPLETED	Sham Discontinuation	3

Source ClinicalTrials.gov

Adverse events2

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Behavior	Psychiatric disorders	Real Discontinuation	9	26	9
other	Behavior	Psychiatric disorders	Sham Discontinuation	3	35	3

Source ClinicalTrials.gov

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Real Discontinuation	0	26
Total, all-cause mortality	Sham Discontinuation	1	35
Total, other adverse events	Real Discontinuation	9	26
Total, other adverse events	Sham Discontinuation	3	35
Total, serious adverse events	Real Discontinuation	0	26
Total, serious adverse events	Sham Discontinuation	0	35

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons3

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Real Discontinuation vs Sham Discontinuation: Successful Completion	Trial comparisons
Real Discontinuation vs Sham Discontinuation: deaths from any cause	Trial comparisons
Real Discontinuation vs Sham Discontinuation: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT02248636

GET https://conductscience.org/api/trials/v1/NCT02248636/registered

API reference For AI assistants