The Use of Galantamine (Reminyl ER) in Patients With MIXed Dementia: Effects on Cognition and Quality of Life

• Status: Completed
• Trial end date: 2009-10-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the combination of galantamine with nimodipine in patients with mixed dementia on cognition and quality of life.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Janssen-Cilag Farmaceutica Ltda.
• Treatments: Galantamine; Nimodipine

Criteria

Inclusion Criteria:

• Patients should fulfill DSM-IV criteria for dementia (APA, 1994)

• Patients should fulfill criteria for AD with cerebrovascular disease according to NINDS-AIREN criteria (Román et al., 1993)

• The severity of dementia should be mild to moderate, as defined by MMSE score between 10 and 26 (inclusive)

• Patients (and their legally acceptable representatives) must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study.

Exclusion Criteria:

• History of neurodegenerative disorders such as Parkinson's disease, Pick's disease or Huntington's chorea, Down's syndrome, Creutzfeldt-Jacob disease. Patients who have mild extrapyramidal signs, for which no treatment is required, are not excluded from the trial

• History of liver or renal insufficiency

• significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurological, psychiatric, or metabolic disturbances in the past 6 months

• Patients who have previously received M1 agonists or cholinesterase inhibitors (tacrine, donepezil, metrifonate, rivastigmine) for treatment of Alzheimer's disease, no matter if approved or experimental can be included in this trial provided there was at least a washout period of 60 days prior to the screening assessments

• History of drug or alcohol abuse within the last year or prior prolonged history

• History of severe drug allergy or hypersensitivity

• including recorded hypersensitivity to cholinesterase inhibitors, choline agonists or similar agents, or bromide

• Subjects who have previously been enrolled in other galantamine trials.