Cholinesterase Inhibitor Discontinuation

NCT02248636 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: CLIN-014-13F
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

Dementia

Keywords

Alzheimer's disease; Cholinesterase inhibitor; Discontinuation

Outcome Measures

Primary Outcomes (1)

• Successful Completion

  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.

  6 weeks

Secondary Outcomes (5)

• Caregiver Burden

  6 weeks

• Veteran Cognition

  6 weeks

• Veteran Functioning

  6 weeks

• Behavioral Symptoms

  6 weeks

• Post-study Treatment Choice

  12 weeks

Study Arms (2)

Real discontinuation

EXPERIMENTAL

This group is tapered off their previous cholinesterase inhibitor medication.

Drug: Cholinesterase inhibitor

Sham discontinuation

SHAM COMPARATOR

This group receives their previous cholinesterase inhibitor medication, but in in placebo form.

Drug: Sham discontinuation

Interventions

Cholinesterase inhibitor DRUG

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

Real discontinuation

Sham discontinuation DRUG

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

Sham discontinuation

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (4)

Central Arkansas VHS John L. McClellan Memorial Veterans Hospital, Little Rock, AR

Little Rock, Arkansas, 72205-5484, United States

Location

Boise VA Medical Center, Boise, ID

Boise, Idaho, 83702, United States

Location

Edith Nourse Rogers Memorial Veterans Hospital, Bedford, MA

Bedford, Massachusetts, 01730, United States

Location

VA Puget Sound Health Care System Seattle Division, Seattle, WA

Seattle, Washington, 98108, United States

Location

MeSH Terms

Conditions

Dementia; Alzheimer Disease

Interventions

Cholinesterase Inhibitors

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders; Tauopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Cholinergic Agents; Neurotransmitter Agents; Physiological Effects of Drugs

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.

Results Point of Contact

• Title: William Banks, Associate Chief of Staff for Research
• Organization: Puget Sound VA

william.banks4@va.gov

206 764-2701

Study Officials

• Stephen M Thielke, MD

  VA Puget Sound Health Care System Seattle Division, Seattle, WA

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 22, 2014
• First Posted: September 25, 2014
• Study Start: January 22, 2015
• Primary Completion: October 1, 2019
• Study Completion: October 1, 2019
• Last Updated: October 23, 2020
• Results First Posted: October 23, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)