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O4‐06‐05: PF‐04447943: A phase II controlled clinical trial of a selective PDE9A inhbitor in Alzheimer's disease
Author(s) -
Schwam Elias,
Evans Rebecca,
Nicholas Timothy,
Chew Robert,
Davidson Wendy,
Ambrose Darlene,
Altstiel Larry
Publication year - 2011
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.2011.05.2009
Subject(s) - placebo , medicine , memantine , concomitant , clinical global impression , dementia , disease , pathology , alternative medicine
study was to test the efficacy of using the Non Invasive Cortical Enhancement (NICE , Neuronix Ltd., Israel) System, which provides rTMS interlaced with cognitive training (rTMS-COG), for the treatment of Alzheimer’s disease (AD) patients compared with a sham device (double blind design) Methods: Twelve mild to moderate AD patients (6 treatment, 6control), [DSM-IVR criteria; Mini Mental Status Examination (MMSE) of 18 to 24], were recruited. Treatment patients were subjected to 30 daily sessions of rTMS while simultaneously performing COG tasks (45 minutes duration each; 6 weeks), followed by bi-weekly maintenance sessions for 3 more months. Six cortical brain regions (selected in each patient by brain MRI), were stimulated. COG was specifically developed according to the regions stimulated. Control patients followed the same potocol while exposed to a sham device. Treatment effects were assessed using: Alzheimer’s Disease Assessment Scale Cognitive (ADASCog (primary outcome), Alzheimer’s Disease Assessment Scale Activities of Daily Living (ADAS ADL), MMSE and Clinical Global Impression of Change scale (CGIC). Results: ADAS-cog results showed average improvements of -4.5points after 6 weeks in the treatment group compared to -0.87 in the control group and -3.93 points after 4.5 months in the treatment group compared to -0.12 in the controls (p1⁄4 0.06 and p1⁄4 0.09 respectively). Results showed baseline dependence in the treatment group (r 1⁄4 0.8). No side effects were reported, and patient compliance remained high throughout the study). CGIC results of treatment patients at 6 weeks were 3.4 and controls 4.4, while at 20 weeks results of treatment patients were 3.6 and controls 4.6 and controls 4.6. Conclusions: Based on the above results, rTMS-COG (the NICE system) seems to offer a valuable tool for the treatment of cognitive functions in ADpatients.