Cholinesterase Inhibitor Discontinuation (CID)
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|ClinicalTrials.gov Identifier: NCT02248636|
Recruitment Status : Recruiting
First Posted : September 25, 2014
Last Update Posted : May 23, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Dementia||Drug: Cholinesterase inhibitor Drug: Sham discontinuation||Phase 2 Phase 3|
There are no reliable findings from controlled trials about discontinuation of cholinesterase inhibitors from a patient and family perspective. It is unknown at what point these medications do not have effects, and how they can safely be discontinued.
The investigators will identify Veterans who have been taking a cholinesterase inhibitor (CI) (donepezil or galantamine) for at least one year. After informed consent, the investigators will randomize them to Real Taper (half-dose of the CI they had taken for 3 weeks, then placebo for 3 weeks), or Sham Taper (continued full dose of the CI they had taken for 6 weeks). The pills will be blinded by over-encapsulating of the drug or placebo.
An intake interview will ascertain history and measure behaviors, cognitive symptoms, and mood, as well as caregiver burden. Phone calls will assess treatment use and adverse events at week 2 and week 4. An exit interview at week 6 will measure the same variables as at baseline. Participants will be unblinded at that point so they will know which treatment had been used. A follow-up call at 12 weeks will ascertain ongoing treatment and any further adverse events.
At any point in the study, participants and caregivers will be able to return to their pre-study dose of medication.
The primary outcome is the percentage of participants who successfully complete a 6-week discontinuation. This will be compared between arms. Other outcomes related to medical events (e.g. hospitalizations, falls), symptoms (e.g. cognition, behaviors), and caregiver distress will be measured and compared.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Cholinesterase Inhibitor Discontinuation|
|Actual Study Start Date :||January 22, 2015|
|Estimated Primary Completion Date :||October 1, 2019|
|Estimated Study Completion Date :||October 1, 2019|
Experimental: Real discontinuation
This group is tapered off their previous cholinesterase inhibitor medication.
Drug: Cholinesterase inhibitor
This group receives a half-dose of their previous cholinesterase inhibitor medication (in overencapsulated form) for two weeks, then receives placebo.
Sham Comparator: Sham discontinuation
This group receives their previous cholinesterase inhibitor medication, but in in placebo form.
Drug: Sham discontinuation
This group receives their previous dose of cholinesterase inhibitor medication, but in overencapsulated form
- Successful completion [ Time Frame: 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.
- Medical events [ Time Frame: 6 weeks ]Death, hospitalization, fall, urgent medical visit
- Caregiver burden [ Time Frame: 6 weeks ]Zarit caregiver burden scale
- Veteran cognition [ Time Frame: 6 weeks ]Severe Cognitive Impairment Profile
- Veteran functioning [ Time Frame: 6 weeks ]Alzheimer's Disease Cooperative Study Activities of Daily Living (ADL) scale
- Behavioral symptoms [ Time Frame: 6 weeks ]Neuropsychiatric Inventory, brief version
- Post-study treatment choice [ Time Frame: 12 weeks ]Veteran and caregiver decision about what treatment to use (pre-study medication, no treatment)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02248636
|Contact: Stephen M Thielke, MD||(206) 764-2815||Stephen.Thielke@va.gov|
|Contact: Erica Martinez, BS||(206) firstname.lastname@example.org|
|United States, Arkansas|
|Central Arkansas VHS John L. McClellan Memorial Veterans Hospital, Little Rock, AR||Recruiting|
|Little Rock, Arkansas, United States, 72205-5484|
|Contact: Kalpana Padala, MD 501-257-2044 email@example.com|
|Contact: Kim Dean, MS 501-257-2120 firstname.lastname@example.org|
|United States, Idaho|
|Boise VA Medical Center, Boise, ID||Completed|
|Boise, Idaho, United States, 83702|
|United States, Massachusetts|
|Edith Nourse Rogers Memorial Veterans Hospital, Bedford, MA||Active, not recruiting|
|Bedford, Massachusetts, United States, 01730|
|United States, Washington|
|VA Puget Sound Health Care System Seattle Division, Seattle, WA||Recruiting|
|Seattle, Washington, United States, 98108|
|Contact: Amy Marsh 206-764-2670 email@example.com|
|Contact: Christopher Click (206) 277-2155 firstname.lastname@example.org|
|Principal Investigator: Stephen M Thielke, MD|
|Principal Investigator:||Stephen M Thielke, MD||VA Puget Sound Health Care System Seattle Division, Seattle, WA|