Response to Donepezil, Drug Plasma Concentration and the CYP2D6 and APOE Genetic Polymorphisms

Plain-language summary

This study examined the relationship between response to Donepezil (used to treat Alzheimer's disease), the drug's level in the blood, and genetic variations (polymorphisms) in the CYP2D6 and APOE genes. It included patients with probable Alzheimer's who had mild or moderate dementia. It was a non-phase study that has been completed.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

N/A

Status

Completed

Sponsor

Federal University of Minas Gerais

Start date

6/1/2009

Estimated completion

3/1/2013

Related genes

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

Inclusion Criteria:

* Patients fulfilling the National Institute on Aging and the Alzheimer's Association diagnostic criteria of probable AD dementia or the NINDS-AIREN (National Institute of Neurological Disorders and Stroke and Association Internationale pour la Recherché et l'Enseignement en Neurosciences) diagnostic criteria of AD with cerebrovascular disease (AD + CVD)
* Patients presenting mild or moderate dementia according to the Clinical Dementia Rating (CDR), i.e., CDR 1 or 2, respectively

Exclusion Criteria:

* Patients treated with ChEI or memantine before study entry
* Patients diagnosed with frontotemporal dementia, dementia with Lewy bodies or vascular dementia,
* Patients classified as CDR 3 or with Mild Cognitive Impairment
* Illiterate patients
* Disagreement between the first investigator and the treating physician regarding the diagnosis