Status:
COMPLETED
The Use of Galantamine (Reminyl ER) in Patients With MIXed Dementia: Effects on Cognition and Quality of Life
Lead Sponsor:
Janssen-Cilag Farmaceutica Ltda.
Conditions:
Dementia
Eligibility:
All Genders
65+ years
Phase:
PHASE4
Brief 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.
Detailed Description
A double-blind (neither the patient nor the physician know the name of the study drug), 6-month, multicenter, placebo-controlled trial to evaluate the combination of galantamine with nimodipine in pat...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2009
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT00814658
Start Date
June 1 2008
End Date
October 1 2009
Last Update
August 26 2013
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