October 22, 2007
Memory Pharmaceuticals reported negative results from a phase IIa trial of MEM1003 for the treatment of Alzheimers disease (AD). This randomized, double-blind, placebo-controlled study enrolled 183 subjects with mild to moderate AD in the US. Enrollment included a subgroup of subjects on stable doses of cholinesterase inhibitors and a subgroup on MEM1003 monotherapy. During the double-blind phase, subjects received one of two doses of the drug (30 mg or 90 mg) or placebo twice daily for 12 weeks. This was followed by a 4 week single blind placebo treatment period. The primary efficacy endpoint for the trial was change in 12-week score on the Alzheimer's Disease Assessment Scale -- Cognitive subscale (ADAS-cog). The primary endpoint was not reached due to a large placebo response in the subgroup of monotherapy subjects. In the subgroup of subjects receiving cholinesterase inhibitors, the change in ADAS-cog favored treatment over placebo, although this difference was not statistically significant. This sub-group also reached all secondary endpoints. Treatment was well tolerated, with adverse events similar across all treatment arms. Based on the results, Memory plans to continue with the development of MEM1003 for this population.
January 15, 2007
Somaxon issued positive results from a phase III trial of Silenor for the treatment of insomnia in elderly subjects. This randomized, double-blind, placebo-controlled, multi-center, parallel group trial enrolled 240 elderly subjects who received placebo or Silenor at 1 mg or 3 mg, for 12 weeks. Treatment was well tolerated, with adverse events similar to placebo. Statistically significant improvement was seen in the primary endpoint, Wake After Sleep Onset (WASO) measured at night one, for both doses studied (1mg: p=0.0053, 3mg: p less than 0.0001). Statistical significance for this endpoint was also achieved at the end of the twelve week treatment period for both doses studied (1mg: p=0.0330, 3mg: p less than 0.0001) . In addition, both doses resulted in statistical significance over placebo in Total Sleep Time (TST), Sleep Efficiency (SE) and subjective Total Sleep Time (sTST). Both doses of Silenor demonstrated improvements relative to baseline in Latency to Persistent Sleep (LPS), but statistical significance versus placebo was not observed. Based on positive phase III results, Somaxon planned to file a NDA with the FDA in Q3 of 2007.
October 3, 2005
Myriad Genetics announced positive results of a phase II follow-up trial of Flurizan, for the treatment of Alzheimer's disease (AD). Trial data from the 3-month follow-up period indicated that subjects receiving high dose Flurizan did not experience symptomatic disease progression: over the first 12 months of treatment (the start of the follow-up), subjects experienced a average decline of 2.8 points on the ADAS-cog diagnostic scale; at month 15, at the end of the follow-up, average ADAS-cog decline relative to baseline was 2.7 points, an improvement of 0.1 points. Symptom severity score on the CDR-sb scale yielded a rate of decline in score over months the extension period (months 12-15) was 0.03 points per month, compared to 0.11 points-per-month during the original study (months 0-12), indicating potentially slowed disease progression. This 3-month open-label extension study enrolled 81% of patients from the original trial; patients who had received Flurizan in the original 12-month study continued to receive their original dose, and subjects who received placebo were switched to 400 mg or 800 mg twice daily.
March 21, 2005
Axonyx announced positive interim results of a phase IIb trial of Phenserine tartrate, for the treatment of mild-to-moderate Alzheimer's disease. These data were also presented at the 7th International Conference on Alzheimer's and Parkinson's disease in Sorrento, Italy. Study results yielded evidence of efficacy in the primary endpoint, producing a reduction in cerebrospinal fluid beta-amyloid concentrations at both dose levels (low dose:-1.16 pg/ml, high dose: -35.65 pg/ml) compared to an increase in concentrations among subjects receiving placebo (+22.38 pg/ml). In the interim data analysis, neither reduction achieved statistical significance, but the reduction observed for the high dose group was sufficiently large to warrant continued enrollment and treatment in the trial. This double-blind placebo-controlled trial had enrolled 37 subjects to date, who were randomized to receive one of two doses of the drug (10 mg, n=11; or 15 mg, n=19) or placebo (n=7) twice daily for 6 months. The company announced that trial data warranted continued enrollment in the 15 mg dose group, which was expected to be completed in the second quarter of 2005, with final results expected before the end of the year.
July 8, 2002
Phase II trial results indicate that treatment with Neurocrine Biosciences' indiplon-MR (modified release formulation) tablets improves sleep maintenance in elderly subjects with primary insomnia characterized by sleep maintenance difficulties. The randomized, multicenter, double-blind, dose-response trial evaluated four dose levels of indiplon-MR (10, 20, 30 and 35 mg). Results showed that the 20, 30 and 35 mg indiplon-MR doses produced a highly statistically significant improvement in the primary endpoint of sleep efficiency - defined as total sleep time divided by total bed time - compared to placebo. Total sleep time was also statistically significant compared to placebo, in addition to secondary sleep maintenance endpoints, including wake time after sleep onset and wake time during sleep.
February 4, 2002
Study results indicate that treatment with Aricept (donepezil hydrochloride) significantly improves the cognitive and global function of vascular dementia (VaD) subjects compared to placebo. The double-blind, randomized, placebo-controlled trial included subjects with VaD and excluded those with a diagnosis of Alzheimer's disease. Subjects treated with Aricept (5 mg or 10 mg) showed significant improvement in their cognitive function compared to placebo-treated subjects as measured by the Alzheimer's Disease Assessment Scale (ADAS-cog). Aricept also produced significant improvements in global function compared to placebo, as measured by the Clinician's Interview-Based Impression of Change with caregiver input (CIBIC-plus). Aricept is being developed according to a partnership between Pfizer and Eisai.