Clinical trial NCT00814658: The Use of Galantamine (Reminyl ER) in Patients With MIXed Dementia: Effects on Cognition and Quality of Life
Official title: The Use of Galantamine (Reminyl ER) in Patients With MIXed Dementia: Effects on Cognition and Quality of Life
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Dementia
Keywords: Dementia
Mixed Dementia
Galantamine
Reminyl ER
Nimodipine
Lead sponsor: Janssen-Cilag Farmaceutica Ltda.
Sponsor class: INDUSTRY
First posted: 2008-12-25
Enrollment: 22
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 patients with mixed dementia on cognition and quality of life. The target dose of galantamine is 24 mg/day and nimodipine will be taken in fixed doses of 90 mg/day. Primary outcomes will be measured by a computerized battery of neuropsychological tests and Quality of Life (QoL) scores. Secondary outcomes will be measured by ADAS-cog, Clinical Global Impression (CGI) and Neuropsychiatric Inventory (NPI). Mixed dementia (Alzheimer's Disease (AD) associated with cerebrovascular disease) is one of the most common causes of dementia, which remain largely underdiagnosed. Little is known about specific treatments for this condition. Ischemic lesions by themselves seem to play an important role in cognitive impairment, even in the presence of AD pathology. Hypotheses: - Galantamine 16-24 mg/day in combination with nimodipine 90 mg/day is superior to galantamine monotherapy (16-24 mg/day) in improving or stabilizing cognition in patients with AD associated with cerebrovascular disease (mixed dementia), as measured by the CNTB at 6 months. - Galantamine 16-24 mg/day in combination with nimodipine 90 mg/day is superior to galantamine monotherapy (16-24 mg/day) on QoL measures in this population as measured by QoL - AD at 6 months. Group 1: galantamine oral 8mg/day for a month, 16mg/day for 4 weeks and after 24mg/day until end of study plus nimodipine oral 30mg tid during all study. Group 2: Group 1: galantamine oral 8mg/day for a month, 16mg/day for 4 weeks and after 24mg/day until end of study plus placebo oral 30mg tid during all study.

Eligibility 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.

Primary outcomes:
measure: Reaction Time for Simple Reaction Time Test at Baseline, Week 8, and Week 24
timeFrame: Baseline, Week 8, Week 24
measure: Reaction Time for Two-choice Reaction Time Test at Baseline, Week 8, and Week 24
timeFrame: Baseline, Week 8, Week 24
measure: Reaction Time for Face Recognition Test at Baseline, Week 8, and Week 24
timeFrame: Baseline, Week 8, Week 24
measure: Reaction Time for Word Recognition and Learning Test at Baseline, Week 8, and Week 24
timeFrame: Baseline, Week 8, Week 24
measure: The Quality of Life Assessment for Caregivers of Patients With Alzheimer's Disease (QoL- AD) Total Scores at Baseline, Week 8, Week 24
timeFrame: Baseline, Week 8, Week 24
measure: The Quality of Life Assessment for Patients With Alzheimer's Disease (QoL- AD) Total Scores at Baseline, Week 8, Week 24
timeFrame: Baseline, Week 8, Week 24
measure: The Quality of Life Assessment for Patients With Alzheimer's Disease (QoL- AD) Total Scores, Based on the Caregiver's Opinion, at Baseline, Week 8, Week 24
timeFrame: Baseline, Week 8, Week 24
Secondary outcomes:
measure: The Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog) at Baseline, Week 8, and Week 24
timeFrame: Baseline, Week 8, Week 24
measure: The Clinical Global Impression (CGI) at Week 4, Week 8, Week 16, and Week 24
timeFrame: Week 4, Week 8, Week 16, Week 24
measure: The Neuropsychiatric Inventory (NPI) at Baseline, Week 8, and Week 24
timeFrame: Baseline, Week 8, Week 24
Other outcomes:
Locations:
Study officials:
affiliation: Janssen-Cilag Farmaceutica Ltda.
name: Janssen-Cilag Farmaceutica Ltda. Clinical Trial
role: STUDY_DIRECTOR
References:
citation: Caramelli P, Laks J, Palmini AL, Nitrini R, Chaves ML, Forlenza OV, Vale Fde A, Barbosa MT, Bottino CM, Machado JC, Charchat-Fichman H, Lawson FL. Effects of galantamine and galantamine combined with nimodipine on cognitive speed and quality of life in mixed dementia: a 24-week, randomized, placebo-controlled exploratory trial (the REMIX study). Arq Neuropsiquiatr. 2014 Jun;72(6):411-7. doi: 10.1590/0004-282x20140055.