January 24, 2011
Targacept issued positive results from a phase II trial of TC-5619 for cognitive dysfunction in schizophrenia. This double blind, placebo controlled trial enrolled 185 subjects across the U.S. and India. The subjects received either TC-5619 (1mg daily for the first four weeks, 5mg daily dose for the next four weeks and 25mg daily dose for the last four weeks) or placebo, together with continued treatment of an approved antipsychotic, for 12 weeks. The primary endpoint was the change from baseline on the Groton Maze Learning item of the CogState Schizophrenia Test Battery (GMLT). The GMLT results met the pre-defined criteria, as well as at two of the trials three measurement dates, at 4 weeks and at 12 weeks. Positive results were also observed for several secondary efficacy outcome measures, including Scale for Assessment of Negative Symptoms, Clinical Global Impression Global Improvement, and Subject Global Impression Cognition scale.
September 8, 2008
Allon reported negative results from a phase II trial of AL-208 for the prevention or reduction of mild cognitive impairment (MCI) in subjects undergoing coronary artery bypass graft (CABG) surgery. This study enrolled 234 subjects in the United States and Canada. It consisted of an open label safety stage and a randomized, double-blind, placebo controlled stage. The active group was administered 300 mg of AL-208 as a 15-minute intravenous infusion 30 minutes prior to being placed on the bypass pump. The placebo group received an intravenous infusion of saline under the same conditions. The primary endpoints were a series of executive function and memory tests, as well as executive function and memory composite scores comprised of the individual tests. Approximately two weeks after surgery, subjects in both the treated and placebo groups performed at a level similar to age-matched normal adults on executive function and memory tests, indicating that neither group was significantly impaired, and that the single-dose has no observable effect because no functional deficit was present. Based on the results, Allon plans to re-focus development of AL-208 as a second generation Alzheimer's product.
September 3, 2007
Accera announced positive results from a phase II trial of Ketasyn for the treatment of age-associated memory impairment (AAMI). This US based, randomized, double-blind, placebo-controlled, parallel trial enrolled 159 subjects with a mean age of 65 who were diagnosed with AAMI. The subjects received Ketasyn or placebo for 90 days followed by a two-week washout period. They subsequently underwent genomic testing for variations in coding regions of genes known to influence memory and cognition, including the apolipoprotein E4 gene (APOE4). On days 0, 30, 60, 90 and 104, the subjects were evaluated through a battery of neuropsychometric tests to measure cognition and memory. Results showed subjects taking Ketasyn performed significantly better on the First-Last Name Association (FLN) test and on the Name-Face Recognition (NFA) test at day 90 (p=0.042 and p=0.0217, respectively). The subjects who did not have the APOE4 genotype, APOE4(-), showed a further significant treatment effect with Ketasyn compared to placebo in FLN at day 90 (p=0.012). The subjects who were APOE4(+) showed no difference between Ketasyn and placebo for FLN scores at Day 90 (p=0.4639). Treatment was well tolerated, with adverse events similar between the active and placebo groups. Based on the results, Accera plans to initiate a phase III trial in early 2008.
Neurochem reported negative results from a phase III trial of Alzhemed for the treatment of Alzheimers disease (AD). This randomized, double-blind, placebo-controlled, three-armed and parallel-designed, 18-month trial enrolled 1,052 subjects with mild-to-moderate AD in the United States and Canada. Subjects received either placebo or one of two doses of Alzhemed (100 mg or 150 mg) twice daily. Treatment with Alzehemed did not demonstrate a statistically significant improvement over placebo with respect to the primary endpoints of efficacy and disease modification. However, a statistically significant difference was observed in hippocampal volume between the Alzehemed and placebo treatment groups. Neurochem plans to use this data to modify the study design of an ongoing European phase III clinical trial.
Transition and Elan released positive results from several phase I trials of ELND-005/AZD-103 for the treatment of Alzheimers disease. These single and multiple ascending dose trials enrolled a total of 110 healthy subjects. Treatment was safe and well-tolerated at all doses and dosing regimens examined, with no reported adverse events. ELND-005/AZD-103 was also shown to be orally bioavailable, cross the blood-brain barrier and achieve levels in the human brain and CSF that were shown to be effective in preclinical animal models for Alzheimer's disease. Based on the results, Transition and Elan plan to commence phase II trials by the end of 2007 or early 2008.
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.
April 4, 2005
Saegis Pharmaceuticals reported positive results from a phase I trial investigating SGS518, a selective antagonist of the 5-HT6 serotonin receptor for the treatment of Cognitive Impairment Associated with Schizophrenia (CIAS). The drug is thought to enhance brain chemical transmission. Clinical results found the drug to be safe and well tolerated. The placebo-controlled, blinded study enrolled healthy subjects who were dosed in two cohorts: a single-dose, dose-ranging arm, followed by a multi-dose arm. The study’s primary objective was to evaluate the safety, tolerability and pharmacokinetics of SGS518. Saegis is developing SGS518 in partnership with Eli Lilly.