CompletedPhase 3

Optimal Dose Escalation Strategy to Successful Achievement of High Dose Donepezil 23mg

South Korea176 participantsStarted 2014-12

Plain-language summary

This study evaluates the side effects of dose escalation in the treatment of donepezil 23mg for patients with Alzheimer's disease. Investigators randomly divide participants into three groups according to the dose escalation method; no titration, 15mg of donepezil for a month before escalation to 23mg, and alternating of 10mg and 23mg for a month before escalation to 23mg.

Who can participate

Age range45 Years – 90 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * dementia according to Diagnostic and Statistical Manual of Mental Disorders (DSM)-IV criteria * probable Alzheimer's disease dementia according to National Institute on Aging-Alzheimer's Association (NIAAA) criteria * Mini-Mental State Examination (MMSE) score of 20 or less * General Deterioration Scale (GDS) score of 4 or more / Clinical Dementia Rating (CDR) score of 2 or more * stable dose of 10mg donepezil at least 3 months before screening * caregiver who can come together at every visit and give informations about side effects profiles should exist * patients and caregivers accepted the study Exclusion Criteria: * patients receiving other concomitant acetylcholinesterase inhibitor * uncontrolled psychiatric disorders * drug overuse or alcohol abuse history within 5 years * significant uncontrolled or active medical conditions * uncontrolled epilepsy * patients who cannot come at scheduled visits

What they're measuring

Incidence of treatment-emergent adverse events (safety and tolerability)

Timeframe: Change from baseline at 4 week

Trial details

NCT IDNCT02550665

SponsorAsan Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2016-08