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P3‐023: Increasing Frailty was Associated with a Greater Chance of Not Attaining Goals in the Vista Clinical Trial of Galantamine
Author(s) -
Rockwood Michael R.H.,
Schindler Rachel,
Howlett Susan E.,
Rockwood Kenneth
Publication year - 2016
Publication title -
alzheimer's and dementia
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 6.713
H-Index - 118
eISSN - 1552-5279
pISSN - 1552-5260
DOI - 10.1016/j.jalz.2016.06.1680
Subject(s) - galantamine , placebo , medicine , dementia , clinical trial , randomized controlled trial , physical therapy , donepezil , disease , alternative medicine , pathology
Background:Acetylcholinesterase inhibitor (AChEI) and Memantine are recognized drug treatments with limited clinical efficacy. Combination therapy for patients with Alzheimer’s disease (AD) was suggested, but the additional benefit of combination therapy is still controversial. To evaluate the additional benefit of combination therapy over monotherapy with either AChEI or Memantine. Methods: Prospective randomized controlled trials were searched from the OVID databases. The trials were eligible if study subjects were diagnosed with AD, and were randomized to compare combination therapy with monotherapy. Any clinical assessment measured using validated scales on cognitive function, activities of daily living, behavioral problems and global changes were the primary outcomes, and any reported adverse events were the secondary outcomes. Quality of studies and risk of bias were evaluated. Results: Fourteen randomized trials were identified between 2004 and 2015 from the United States, Canada, Germany, Japan, China and Korea. A total of 5,020 subjects with AD were randomly assigned to receive combination therapy of AChEI and Memantine or monotherapy with AChEI or Memantine. Combination therapy showed no significant benefit on cognitive function (Mean difference (MD) of MMSE1⁄40.11, 95% CI -0.40 to 0.61), activities of daily living (MD of ADCS-ADL1⁄4-0.15, 95% CI -1.07 to 0.77), neuropsychiatric symptoms and behavioral problems (MD of NPI1⁄4-1.85, 95% CI -4.83 to 1.13), and global changes (MD of CIBIC-plus 1⁄40.01, 95% CI -0.25 to 0.28). The conclusion is consistent with the results of standardized MD with inclusion of different assessment tools. No additional adverse event was reported in the combination therapy. Conclusions: Combination therapy showed no superiority over monotherapy for Alzheimer’s Disease in terms of cognitive function, activities of daily living, behavioral problems, and global changes. Although reported adverse events were comparable, the additional cost for combination therapy may be unnecessary.