A 12-week, open label, multicentre study assessing the efficcay and of Donepezil in patients discontinuing treatment with Memantine monotherapyEstudio abierto y multicéntrico de 12 semanas de duración para valorar la eficacia y seguridad de Donepezilo en pacientes tras suspender el tratamiento con Memantina en monoterapia

Pfizer, S.A.0 sites100 target enrollmentMarch 30, 2006

DrugsAricept

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Not specified
Sponsor: Pfizer, S.A.
Enrollment: 100
Status: Active, not recruiting
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

March 30, 2006

End Date

July 17, 2006

Last Updated

4 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

Pfizer, S.A.

Eligibility Criteria

Inclusion Criteria

•Patients aged 50 years or over, both men and women. Women of childbearing potential or \<2 year post\-menopausal must be practising an approved method of contraception and have negative serum b\-HCG at screening (women who are breastfeeding are excluded).
•Written informed consent to participation.
•Patients with moderate to severe Alzheimer’s disease with an MMSE score between 5\-17 (inclusive).
•Diagnostic evidence of probable or possible Alzheimer’s disease consistent with DSM\-IV and NINCDS\-ADRDA criteria made by the site physician at the time of the screening visit. This evidence must be fully documented in the patient’s file prior to the baseline visit.
•CT or MRI within the last 18 months consistent with a diagnosis of Alzheimer’s disease without any other clinically significant co\-morbid pathologies found. If there has been a significant change in clinical status suggestive of stroke or other possible neurological disease with onset between the time of the last CT or MRI and the screening evaluation, the scan should be repeated if considered appropriate by the investigator.
•The patient must be capable of completing all procedures scheduled during the screening and baseline visits including all efficacy parameters (i.e. psychometric tests).
•Patients must have a reliable caregiver or family member who agrees to accompany the patient to all clinic visits, provide information about the patient as required by the protocol, and ensure compliance with the medication schedule.
•The patient must be currently taking memantine at the recommended dose (10 mg bid) for at least 3 months prior to the screening visit and maintained until the baseline visit.
•Treatment of the patient with memantine is judged by the clinician at the time of screening as lacking efficacy or not well tolerated.
•Clinical laboratory values within normal limits, and within the sponsor’s guidelines, or, if abnormal, considered and documented as not clinically significant by the investigator.

Exclusion Criteria

•Patients with a known hypersensitivity to donepezil, piperidine derivatives, or any of the excipients used in the formulation of donepezil
•Patients with active or clinically significant conditions affecting absorption, distribution or metabolism of the study medication.
•Patients who have been treated with a cholinesterase inhibitor in the 3 months prior to screening visit.
•Patients treated with any investigational drug within 30 days of screening visit.
•Patients without a reliable caregiver, or patients or caregivers who are unwilling or unable to complete any of the outcome measures and fulfill the requirements of this study.
•Nursing home patients will be excluded from entering the study. Likewise, patients for whom institutionalization is being considered within the next 3 months should also be excluded.
•Patients with clinically significant obstructive pulmonary disease or asthma.
•Patients with a recent (\< 2 years) haematologic/oncologic disorders.
•Evidence of active clinically significant and unstable gastrointestinal, endocrine or cardiovascular system disease.
•Evidence of severe hepatic or renal impairment.