O3‐05‐07: Efficacy of memantine in PDD and DLB: An extension study including wash‐out and open‐label treatment
Year: 2010
Type: article
Study design: Clinical Trial
Abstract: Dementia in PD (PDD) and dementia with Lewy bodies (DLB) are common and disabling conditions. Rivastigmine is approved for treatment of PDD, but there are no treatments available for DLB. Recently, small double-blind randomized controlled trials have suggested that memantine is safe and effective for the treatment of DLB and PDD for up to 24 weeks. The objective of this study was to evaluate the clinical change during a 4-week withdrawal phase and a subsequent 24-week continuation phase following a 24-week randomised placebo-controlled trial with memantine. Of the 72 patients enrolled in the trial, 56 entered and 44 (20 placebo and 44 memantine) completed the blinded wash-out phase. 32 patients entered and 26 completed the continuation phase. Outcome measures were presence of discontinuation reaction (pronounced worsening) upon drug withdrawal, and Clinical Global Impression of Change (CGIC) and modified motor Unified Parkinson's Disease Rating Scale (UPDRS). Discontinuation reactions occurred more frequently in patients who had received memantine (58%) than those who had received placebo (25%) (p = 0.04). There was a significant worsening of the CGIC in the memantine (mean 1.4 (SD 1.2); p = 0.0003) but not in the placebo group (0.8(1.4), p = 0.06). The difference in change between the two groups did not reach statistical significance. During the open-label continuation phase, both groups improved as measured by the CGIC. However, due to the small sample size, the improvement did not reach statistical significance (p = 0.15). The memantine-associated benefits were rapidly lost after drug withdrawal, indicating that withdrawal should be monitored carefully. The observed long-term improvement in the open-label treatment phase suggests that a benefit of memantine can be achieved for nearly a year in patients with PDD/DLB. Acknowledgement. This clinician-initiated study received support from H. Lundbeck (unrestricted grant and provision of active drug and placebo), and the Western Norway Health Trust.
Source: Alzheimer s & Dementia
Language: English
Subfield: Neurology
Field: Medicine
Domain: Health Sciences
Open Access status: bronze
OpenAlex ID: W2103493089