Neurochem Reports on Alzheimer's Disease Drug Trial Results
Posted on: Tuesday, 28 August 2007, 12:16 CDT
Neurochem has reported disappointing top-line results from its Phase III clinical trial designed to assess the safety, efficacy and disease modification effect of Alzhamed for the treatment of Alzheimer's disease.
Following a meeting with the FDA and subsequent statistical analyses, the company reported that despite the descriptive data showing numerical differences, the drug did not demonstrate a statistically significant difference in favor of Alzhamed with respect to the primary endpoints over 18 months of treatment.
Due to significant interference from high between-site variations that complicated the statistical analyses beyond expectations, Neurochem says it is not possible to draw definitive conclusions with respect to the treatment of Alzhamed.
At the recent FDA meeting, the company says it sought feedback on appropriate next steps, especially with respect to the statistical models and the detailed analysis of potential confounding factors. Neurochem says the agency recognized the difficult issues surrounding a trial of this magnitude, with its significant site effect and the large number of covariates identified during the modeling process, and advised that neither the proposed adjusted models nor any further adjustments could be used for this trial to provide results in support of a claim of clinical efficacy.
Neurochem says it will continue to evaluate the treatment effect of the drug.
Source: Datamonitor
Related Articles
- Sangamo BioSciences Announces Presentation of Top-Line Statistically Significant Phase 2 Data in Diabetic Neuropathy at Society for Neuroscience Meeting
- Spectra Energy Reports No Significant Damage or Effects to Operations Found To-Date As Result of Hurricanes
- Pharmacopeia's First-in-Class Investigational Therapy PS433540 Achieves Statistically Significant Reductions in Blood Pressure in Hypertensive Patients
- Phase III Data Showed Taranabant, Merck's Investigational Medicine to Treat Obesity, Led to Statistically Significant Weight Loss
- Addex Achieves Statistically Significant Outcome in Phase IIa Clinical Trial With ADX10059 in Gastro-Esophageal Reflux Disease
- Repros' Proellex Shows Statistically Significant Improvement in Primary Endpoint in Phase 2 Trial in the Treatment of Uterine Fibroids
- Repros' Proellex Shows Statistically Significant Improvement in Bleeding and Pain in Phase 2 Trial
- Repros Reports Proellex Achieves Statistically Significant Pain Reduction in Endometriosis Trial
- DOV Pharmaceutical, Inc. Announces Statistically Significant Analgesic Effects of Bicifadine in Phase III Clinical Trial in Patients Following Bunionectomy Surgery
- Actelion: Second Study With Bosentan (Tracleer) Demonstrating a Statistically Significant Reduction of New Digital Ulcers in Patients With Systemic Sclerosis
 |
 |
User Comments (0)
RSS Feeds