AC-1204 Found Safe for Treatment of Mild-to-Moderate Alzheimer's Disease in Phase 3 Study
Accera, Inc. announced results of the AC-1204 Phase 3 study for the treatment of mild-to-moderate Alzheimer's disease.
Patients treated with AC-1204 did not demonstrate a statistically significant difference at 26 weeks compared with patients treated with placebo, as measured by the Alzheimer's disease Assessment Scale-Cognitive Subscale test. In the study, AC-1204 was shown to be safe and demonstrated high levels of tolerability with the most prevalent adverse event being only mild, transient gastrointestinal disturbance. A detailed pharmacokinetic analysis has shown that the modified AC-1204 formulation used in the study resulted in lower drug plasma levels than prior formulations. This suboptimal exposure contributed to the lack of efficacy observed in the trial.
Source.“Accera Announces Results of its First Phase 3 Study in Mild-to-Moderate Alzheimer's Disease.” (2017, February 28). Retrieved March 27, 2017, from http://prn.to/2m2TcV1.
Donepezil May Accelerate Cognitive Decline in Individuals With BChE-K Gene
Donepezil, a medication that is approved to treat individuals with Alzheimer's disease, should not be prescribed for those with mild cognitive impairment (MCI) without a genetic test. UCLA School of Nursing researchers discovered that for individuals who carry a specific genetic variation—the K-variant of butyrylcholin-esterase (BChE-K)—donepezil could accelerate cognitive decline.
Donepezil was tested as a possible treatment for MCI in a large, federally funded study published in 2005, but it was not approved by the U.S. Food & Drug Administration. From data collected during the 2005 trial, researchers looked at the association between BChE-K and changes in cognitive function. Using two tests that measure cognitive impairment, the Mini-Mental State Examination and the Clinical Dementia Rating Sum of Boxes, they found that individuals with the genetic variation who were treated with donepezil had greater changes in their scores than those who took placebos. They also found that those who took donepezil had a faster cognitive decline than those who took the placebo.
The findings reinforce the importance of physicians discussing the possible benefits and risks of this treatment with their patients.
Source.“Alzheimer's Drug Prescribed ‘Off-Label’ for Mild Cognitive Impairment Could Pose Risk for Some.” (2017, February 24). Retrieved March 27, 2017, from http://bit.ly/2o6z9Ha.