Clinical Trials Resource Center

New Medical Therapies™

Memory Loss

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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.

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.

April 16, 2007

Helicon reported positive preliminary results from a phase IIa trial ofIPL 455for the treatment of age associated memory impairment. This double-blind, randomized placebo controlled trial was designed to evaluate the safety, tolerability, preliminary efficacy and pharmacokinetics of IPL 455 when given in a range of oral doses over a 28 day period. Preliminary data found treatment to be safe and well tolerated at doses up to 15-90 mg per subject per day. Daily administration resulted in sustained drug levels. The effects on memory and learning failed to reach statistical significance in this trial. Full results were expected by the end of April 2007.

Stem Cell Therapeutics released positive interim results from a phase IIa trial ofNTx-265 for the treatment of stroke. The four subjects who had completed therapy to date were enrolled after suffering a stroke of moderate severity and received NTx-265 initiated 24-48 hours after stroke onset. Treatment was well tolerated with no reported serious adverse events. The subjects demonstrated significant recovery from their stroke symptoms. In addition, MRI readings at days 1 and 90 post-stroke, available from two of the subjects, indicated that infarct volume, the volume of brain tissue affected by blockage of blood flow to that tissue, had been reduced by 39-79% over a 90-day period. Final results from this trial are expected by Q4 of 2007.

Valeant issued positive results from a phase II trial ofretigabine for the treatment of epilepsy. This double-blind trial enrolled 396 subjects aged 16 to 70 internationally. After an initial 8-week baseline period, subjects were randomized to receive retigabine (600, 900 or 1,200 mg/day) or placebo, while maintaining their current therapies. Dosing of retigabine was increased gradually over a period of 8 weeks and then maintained for an additional 8 weeks. Results revealed that the addition of retigabine 600, 900 or 1,200 mg per day significantly reduced median monthly seizure frequency compared to baseline by 23%, 29% and 35%, respectively. Seizure reduction in the 900 and 1,200 mg groups were significantly greater than in the placebo group (13 percent vs. baseline). In addition, the percent of responders (the subjects with a greater than 50% reduction in seizure frequency) was significantly greater for the 900 and 1,200 mg groups than placebo (32% and 33% versus 16%, respectively). Retigabine is currently undergoing international phase III trials.

May 22, 2006

Corgentech issued positive results of a phase III trial of 3268, their fast acting local anesthetic for the prevention of pain associated with venipuncture and intravenous (IV) line placement procedures, at the Society of Academic Emergency Medicine Annual Meeting in San Francisco. Trial data demonstrated significant efficacy in the trial's primary endpoint, reducing mean score on the FACES pain scale prior to needle insertion (p=0.007). A significant reduction was also noted in mean parental observational pain assessment score during venipuncture, vs. placebo (p<0.001). No clinically significant safety concerns were noted. This randomized, double-blind, placebo-controlled study enrolled 574 pediatric patients at 6 sites in the US; subjects received the drug or placebo 1 to 3 minutes before venipuncture procedures.

Targacept and AstraZeneca have issued positive results of a phase II trial of TC-1734 (AZD3480) for the treatment of age-associated memory impairment (AAMI). Results from the study indicated significant improvements for the higher trial dose in three efficacy measures in both the per-protocol population (Atten p=0.010, Mem p=0.030, SGI p=0.008) and the intent to treat population (Atten p=0.014, Mem p=0.029, SGI p=0.015). The lower trial dose achieved significant efficacy in the power of attention endpoint (p=0.023, p=0.025 for the two populations, respectively). This multi-center, randomized, double-blind, placebo-controlled, dose-finding study enrolled 193 patients AAMI without evidence of additional disease at 16 US sites, who received one of two doses of the drug (25 mg or 50 mg) or placebo once daily for 16 weeks.

May 16, 2005

Inflazyme and Helicon announced positive results of a series of phase I trials of their phosphodiesterase-4 (PDE4) inhibitor IPL455,903, for the treatment of cognitive impairment. Data from the studies yielded a positive safety profile, with no serious adverse events reported and no incidence of emesis, a common tolerability concern with PDE4 inhibitors. Pharmacokinetic analysis indicated a clinically useful plasma profile, with drug absorption not strongly influenced by food intake. All the trials in the series were open-label ascending-dose studies, which enrolled a combined 50 healthy adult volunteers. Subjects received a single-dose (5 mg-405 mg) of the drug or placebo orally, and were monitored for safety, tolerability and pharmacokinetics. Based on these results, the companies announced plans for 2-week multiple- ascending dose phase I studies in healthy volunteers, to be followed by phase IIa safety and efficacy studies in subjects with learning and memory disorders.

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.

February 23, 2004

Cortex Pharmaceuticals and Les Laboratoires Servier reported negative results from a study investigating CX516, an AMPA receptor neuronal strengthener for the treatment of mild cognitive impairment (MCI). Results showed the trial failed to meet its primary endpoint, improvements in the 15- item word list delayed recall. Data did show a subset of the subjects with the worst baseline memory impairment, showed substantial improvement with CX516 versus placebo. In addition, safety data showed a significant difference in patient withdrawals in the active treatment group, due to gastrointestinal side effects, compared with placebo. The double-blind, placebo-controlled, cross-national study enrolled 175 subjects at 31 sites in the U.S. and Europe. The primary endpoint was change, between week four and baseline, in the number of words recalled from a 15-item list with delay.

November 3, 2003

Targacept reported positive results from two phase I trials investigating TC-1734, a neuronal nicotinic receptor agonist for the treatment of cognitive and memory disorders. Results showed that no safety issues were reported and positive dose-specific effects on memory and attention measures were demonstrated. Data indicated that the drug achieved rapid absorption and good plasma half-lives. The randomized, double-blind, placebo-controlled studies enrolled a total of 72 healthy subjects. The first trial was a single rising dose study tested over a range of eight escalating doses. The second trial was a multiple rising-dose study tested over a range of three escalating doses.

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