58th Annual Meeting of the American Academy of Neurology: Donepezil and Severe Alzheimer’s Disease

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6 Apr 2010

Donepezil and Severe Alzheimer’s Disease

Speaker: Bengt Winblad, MD, PhD, Professor and Director, Neurotec Department, Division of Geriatrics, Alzheimer’s Disease Research Center, Karolinska Institute and Karolinska University Hospital, Huddinge, Sweden

Donepezil (Aricept canadian, Eisai/Pfizer), well known for its value in the treatment of patients with mild-to-moderate Alzheimer’s disease (AD), has shown substantial benefits in cognition and clinical global improvement in patients with severe AD.

Because cholinesterase inhibitors were thought to be helpful for patients with severe AD, 248 patients at 50 centers in Sweden were enrolled into a six-month, double-blind, placebo-controlled, multicenter trial. They were randomly assigned to take placebo daily for 30 days, followed by donepezil 10 mg daily for the remainder of the study period.

Criteria for enrollment in the study for severe AD included (1) Mini-Mental State Examination (MMSE) scores of 1 to 10 and (2) Functional Assessment and Staging Scale (FASS) scores at stage 5 (patient needs help in selecting proper clothing) to stage 7C (patient unable to walk without assistance).

The overall objectives were to examine the efficacy variables of the MMSE, the Clinical Global Impression of Improvement (CGI-I), and the Neuropsychiatric Inventory (NPI) in order to evaluate cognition, global function, and behavior.

At the six-month follow-up evaluation, for the intent-to-treat (ITT) populations, the donepezil patients showed greater improvement in MMSE scores (1.5) than the placebo patients (0.1). (The ITT population was defined as all randomly selected and treated patients with a baseline efficacy value and at least one corresponding post-baseline efficacy value). CGI-I scores were “much improved,” “improved,” and “minimally improved” with donepezil, compared with placebo.

In general, no differences were observed between the active-treatment patients and the placebo group; both patient groups showed improved NPI scores from the baseline measure to the sixth month. However, a greater (although not statistically superior) improvement was observed with donepezil.

Pramipexole Helps Restless Legs Syndrome

Speaker: John W. Winkelman, MD, PhD, Assistant Professor of Psychiatry, Harvard Medical School, Boston, Massachusetts; Associate Director for Sleep Disorders, Brigham and Women’s Hospital, Boston; and Clinical Director, Sleep Health Center, Newton Centre, Massachusetts

Pramipexole (Mirapex, Boehringer Ingelheim), a dopamine agonist indicated for the signs and symptoms of idiopathic Parkinson’s disease, was found to be safe and effective for patients with restless legs syndrome (RLS).
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Because controlled trials had demonstrated that six weeks of pramipexole treatment improved RLS symptoms, a study was conducted to explore the value of three fixed doses of pramipexole over 12 weeks in patients with RLS. In a double-blind, placebo-controlled, parallel-group study, 344 patients with RLS received 12 weeks of treatment with pramipexole 0.25 mg, 0.50 mg, or 0.75 mg or with placebo. The patients were entered into a four-week titration phase, starting at 0.125 mg and ending at each patient’s randomized dose. The patients then entered an eight-week maintenance phase and received their randomized doses.

Primary efficacy endpoints were (1) changes in total scores of symptom severity on the International Restless Legs Scale (IRLS), compared with baseline examinations through week 12, and (2) CGI-I scores at week 12.

A total of 339 patients were evaluable. The mean baseline IRLS score was 23.4, and 88.5% of patients were rated as at least moderately ill on the CGI-Severity of Illness Scale (CGI-S). At 12 weeks, all three doses of pramipexole produced significant improvements in IRLS total scores, compared with placebo.

The adjusted mean reductions from baseline IRLS scores, for each dose of pramipexole versus placebo, were -12.8 with 0.25 mg (p = .0086), -13.8 with 0.50 mg (p = .0011), -14 with 0.75 mg (p = .0005), and -9.3 with placebo.
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Treatment with pramipexole also resulted in a statistically significant improvement in CGI-I scores, compared with placebo, as measured by the percentage of patients meeting the criteria for a CGI-I responder. The responder rates, for each dose of pramipexole versus placebo, were 74.7% with 0.25 mg (p = .0005), 67.9°% with 0.50 mg (p = .0484), 72.9°% with 0.75 mg (p = .0038), and 51.2°% with placebo.


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