NCT02248636.

Study name	Cholinesterase inhibitor discontinuation (CID)
Methods	Randomised, double‐blind efficacy study, using single group assignment
Participants	72 patients in 2 arms Inclusion criteria Males and females ages 60 and older Taking stable dose of donepezil ≥ 10mg/day, or galantamine ≥ 8mg/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 ChEI medication discontinued. Exclusion criteria Terminal medical condition for which life expectancy is less than 6 months Presence of any uncontrolled systemic illness that would interfere with participation in the study Unstable medical condition Currently driving Receiving services from hospice Current prescription with more than one ChEI Receiving medication in an investigational drug study
Interventions	Experimental: real discontinuation. This group receives a half‐dose of their previous cholinesterase inhibitor medication (in overencapsulated form) for 2 weeks, then receives placebo. Sham comparator: sham discontinuation. This groups receives their previous dose of cholinesterase inhibitor medication, but in an overencapsulated form.
Outcomes	Successful completion, medical events, caregiver burden (Zarit caregiver burden scale), cognition (Severe Cognitive Impairment Profile), functioning (Alzheimer's Disease Cooperative Study ADL Scale (ADCS‐ADL)), neuropsychiatric symptoms (Neuropsychiatric Inventory (NPI), brief version), post‐study treatment choice (patient and caregiver decision about what treatment to use (pre‐study medication, no treatment))
Starting date	January 2015
Contact information	Stephen M Thielke MD, stephen.thielke@va.gov; Erica Martinez BS, erica.martinez@va.gov, USA
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