Cholinesterase Inhibitor Discontinuation
| Status: | Recruiting |
|---|---|
| Conditions: | Alzheimer Disease, Neurology |
| Therapuetic Areas: | Neurology |
| Healthy: | No |
| Age Range: | 60 - Any |
| Updated: | 12/22/2018 |
| Start Date: | January 22, 2015 |
| End Date: | October 1, 2019 |
| Contact: | Stephen M Thielke, MD |
| Email: | Stephen.Thielke@va.gov |
| Phone: | (206) 764-2815 |
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.
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.
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.
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.
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
We found this trial at
3
sites
Seattle, Washington 98108
Principal Investigator: Stephen M Thielke, MD
Phone: 206-764-2670
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Bedford, Massachusetts 01730
Phone: 781-687-2596
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