Myriad Genetics Reports Results of Phase II Trial of Flurizan in Patients With Alzheimer's Disease
Myriad Genetics announced that preliminary results of its Phase II clinical trial of Flurizan did not achieve statistical significance in patients with mild to moderate Alzheimer's disease; however, a positive trend was observed on all three primary endpoints in patients with mild Alzheimer's disease, on the 800 mg twice-daily dose. Additionally, mild Alzheimer's disease patients who achieved high plasma concentrations of Flurizan demonstrated a statistically significant effect in two of the three primary endpoints. The initial findings also indicate that Flurizan was well tolerated in this 12-month, 207 patient clinical study.
The three primary endpoints of the Phase II study were the Alzheimer's Disease Cooperative Study -- Activities of Daily Living inventory (ADCS-ADL), Clinical Dementia Rating -- Sum of Boxes (CDR-sb), and the Alzheimer's Disease Assessment Scale -- Cognitive function subscale (ADAS-cog). Patients with mild Alzheimer's disease who were given the 800 mg twice-daily dose of Flurizan demonstrated a 44 percent slowing of decline in their performance of activities of daily living, as measured by the ADCS-ADL. This assessment measures basic activities of daily living such as dressing and eating.
The 800 mg twice-daily drug-treated group with mild disease at baseline demonstrated a 41 percent slowing of decline during the 12-month study period in global function as measured by the CDR-sb. In this exam, the investigator performs a semi-structured interview with both the patient and the caregiver. The patient's performance is assessed in memory, orientation, judgment, problem solving, community activities, home and hobbies and personal care.
A positive trend was also seen in patients with mild disease on the 800 mg twice-daily dose for the primary cognitive endpoint, ADAS-cog. This group achieved a 29 percent slowing of cognitive decline. The ADAS-cog measures a patient's performance in word recall, response to directions, ability to copy geometric forms, delayed word recall, ability to name objects, memory and quality of speech.
A further analysis of data from 128 mild Alzheimer's disease patients (68 percent of the patients eligible for analysis) indicates that those who achieved the greatest plasma concentrations of Flurizan demonstrated a statistically significant 67 percent reduction in decline in activities of daily living as measured by ADCS-ADL, compared to patients in the placebo group. This finding was confirmed by analyzing the same group of patients versus the control group for the global function assessment, which showed a 54 percent slower decline (p=0.034, two-sided) as measured by CDR-sb. Finally, the high plasma concentration group demonstrated a 30 percent slowing in the rate of decline of cognitive function (not statistically significant), as measured by ADAS-cog.