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A randomized, placebo-controlled trial of latrepirdine in Huntington disease.

ABSTRACT: To evaluate the safety and tolerability of latrepirdine in Huntington disease (HD) and explore its effects on cognition, behavior, and motor symptoms.Double-blind, randomized, placebo-controlled trial.Multicenter outpatient trial.Ninety-one participants with mild to moderate HD enrolled at 17 US and UK centers from July 18, 2007, through July 16, 2008.Latrepirdine, 20 mg 3 times daily (n = 46), or matching placebo (n = 45) for a 90-day treatment period.The primary outcome variable was tolerability, defined as the ability to complete the study at the assigned drug dosage. Secondary outcome variables included score changes from baseline to day 90 on the Unified Huntington's Disease Rating Scale (UHDRS), the Mini-Mental State Examination (MMSE), and the Alzheimer Disease Assessment Scale-cognitive subscale (ADAS-cog).Latrepirdine was well tolerated (87% of the patients given latrepirdine completed the study vs 82% in the placebo group), and adverse event rates were comparable in the 2 groups (70% in the latrepirdine group and 80% in the placebo group). Treatment with latrepirdine resulted in improved mean MMSE scores compared with stable performance in the placebo group (treatment effect, 0.97 points; 95% confidence interval, 0.10-1.85; P = .03). No significant treatment effects were seen on the UHDRS or the ADAS-cog.Short-term administration of latrepirdine is well tolerated in patients with HD and may have a beneficial effect on cognition. Further investigation of latrepirdine is warranted in this population with HD.

SUBMITTER: Kieburtz K

PROVIDER: S-EPMC4134015 | biostudies-literature | 2010 Feb

REPOSITORIES: biostudies-literature

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A randomized, placebo-controlled trial of latrepirdine in Huntington disease.

Kieburtz Karl K McDermott Michael P MP Voss Tiffini S TS Corey-Bloom Jody J Deuel Lisa M LM Dorsey E Ray ER Factor Stewart S Geschwind Michael D MD Hodgeman Karen K Kayson Elise E Noonberg Sarah S Pourfar Michael M Rabinowitz Karen K Ravina Bernard B Sanchez-Ramos Juan J Seely Lynn L Walker Francis F Feigin Andrew A

Archives of neurology 20100201 2

<h4>Objectives</h4>To evaluate the safety and tolerability of latrepirdine in Huntington disease (HD) and explore its effects on cognition, behavior, and motor symptoms.<h4>Design</h4>Double-blind, randomized, placebo-controlled trial.<h4>Setting</h4>Multicenter outpatient trial.<h4>Participants</h4>Ninety-one participants with mild to moderate HD enrolled at 17 US and UK centers from July 18, 2007, through July 16, 2008.<h4>Intervention</h4>Latrepirdine, 20 mg 3 times daily (n = 46), or matchin ...[more]

PMID: 20142523

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Project description:BACKGROUND: Spasticity is a common and poorly controlled symptom of multiple sclerosis. Our objective was to determine the short-term effect of smoked cannabis on this symptom. METHODS: We conducted a placebo-controlled, crossover trial involving adult patients with multiple sclerosis and spasticity. We recruited participants from a regional clinic or by referral from specialists. We randomly assigned participants to either the intervention (smoked cannabis, once daily for three days) or control (identical placebo cigarettes, once daily for three days). Each participant was assessed daily before and after treatment. After a washout interval of 11 days, participants crossed over to the opposite group. Our primary outcome was change in spasticity as measured by patient score on the modified Ashworth scale. Our secondary outcomes included patients' perception of pain (as measured using a visual analogue scale), a timed walk and changes in cognitive function (as measured by patient performance on the Paced Auditory Serial Addition Test), in addition to ratings of fatigue. RESULTS: Thirty-seven participants were randomized at the start of the study, 30 of whom completed the trial. Treatment with smoked cannabis resulted in a reduction in patient scores on the modified Ashworth scale by an average of 2.74 points more than placebo (p < 0.0001). In addition, treatment reduced pain scores on a visual analogue scale by an average of 5.28 points more than placebo (p = 0.008). Scores for the timed walk did not differ significantly between treatment and placebo (p = 0.2). Scores on the Paced Auditory Serial Addition Test decreased by 8.67 points more with treatment than with placebo (p = 0.003). No serious adverse events occurred during the trial. INTERPRETATION: Smoked cannabis was superior to placebo in symptom and pain reduction in participants with treatment-resistant spasticity. Future studies should examine whether different doses can result in similar beneficial effects with less cognitive impact.

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A randomized, placebo-controlled trial of latrepirdine in Huntington disease.

Publications

A randomized, placebo-controlled trial of latrepirdine in Huntington disease.

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