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Safety and tolerability of donepezil in mild cognitive impairment: open-label extension study


Doody, Rachelle S., Ferris, Steven, Salloway, Stephen, Yijun, Sun, Goldman, Robert, Yikang, Xu, Gao, Jeff, Murthy, Anita K.


American Journal Of Alzheimer's Disease And Other Dementias, Volume: 25, No.: 2, Pages.: 155-159

Year of Publication



Following a 48-week, double-blind, randomized, placebo-controlled trial of donepezil in 821 patients with amnestic mild cognitive impairment (aMCI), safety and tolerability of donepezil (10 mg) were further evaluated in a 28-week extension study. Of 499 participants who completed the double-blind phase, 145 enrolled in the open-label study. Adverse events (AEs) were recorded throughout. Overall, 57.4% of participants in the donepezil/donepezil group and 62.3% in the placebo/donepezil group experienced an AE, with the most frequent treatment-emergent AEs being diarrhea, muscle spasms, insomnia, and nausea. Most were mild to moderate in severity and were more common in the first several weeks after treatment initiation. More participants in the placebo/donepezil group (22.1%) discontinued donepezil due to an AE compared with the donepezil/donepezil group (10.3%). These findings support the safety of donepezil in patients with aMCI. When compared with other studies, however, the data suggest that patients with Alzheimer’s tolerate donepezil better than patients with MCI.;

Bibtex Citation

@article{Doody_2009, doi = {10.1177/1533317509352334}, url = {}, year = 2009, month = {nov}, publisher = {{SAGE} Publications}, volume = {25}, number = {2}, pages = {155--159}, author = {R. S. Doody and S. Ferris and S. Salloway and Yijun Sun and R. Goldman and Yikang Xu and J. Gao and A. K. Murthy}, title = {Safety and Tolerability of Donepezil in Mild Cognitive Impairment: Open-Label Extension Study}, journal = {American Journal of Alzheimer{textquotesingle}s Disease and Other Dementias} }


administration & dosage, adult, adverse, adverse effects, aged, aged, 80 and over, amnesia, chemically induced, cholinesterase inhibitors, cognition disorders, diarrhea, donezepil, double-blind method, drug therapy, events, female, humans, indans, male, middle aged, nausea, neuropsychological tests, piperidines, psychiatric status rating scales, psychology, severity of illness index, sleep initiation and maintenance disorders, spasm, time factors, treatment outcome

Countries of Study


Types of Dementia

Mild Cognitive Impairment (MCI)

Types of Study

Randomised Controlled Trial

Type of Outcomes


Type of Interventions

Pharmaceutical Interventions

Pharmaceutical Interventions

Anti-Alzheimer medications, e.g.: donezepil, galantamine, rivastigmine, memantime