We don’t often get a chance to use the words “good news” and “Alzheimer’s Disease” in the same sentence. That may be about to change. You may recall that I have reported on numerous studies here as well as in Europe that have tried to combat the cognitive decline that is the hallmark of Alzheimer’s. Even those therapies that have been approved by the FDA have shown very little impact on the disease, and most of what we have seen clinically is just a modest slowing of the decline. As we said in our book last year:
“Alzheimer’s remains the only disease in the top ten causes of death in the United States that cannot be prevented, cured or slowed.”
Chinese scientists now offer us something worth following. A Shanghai-based company called Green Valley Pharmaceutical Company presented phase 3 clinical trial data at the Alzheimer’s Disease Conference just this past week in Barcelona. In the topline results, researchers reported a rather substantial effect from their treatment, called GDV-971. They randomly sorted a bit more than 800 50 to 80 year old mild to moderate Alzheimer’s patients from 34 different sites across China into experimental and control groups. The experimental group received the 450 mg formulation of GV-971 twice a day for 36 weeks, and the control group received a placebo over this same period in the same dosing.
Using the Mini-Mental State Examination, a standard test for cognitive ability, the researchers saw an effect as early as four weeks into this nine month trial. The separation between the cognitive capabilities of experimental and placebo patients continued through the duration of the trial. Patients had scored between and 11 and a 26 on the scale at the outset of the trial with placebo and experimental group patients manifesting the same mean score. By the 36th week, the experimental group averaged a score 2.54 points higher than the control patients. Statisticians rate this a statistical significance of p<.0001, or in lay terms something that could happen by random chance only once in 10,000 tries.
The active ingredients in the therapy operate in a number of ways that evidently slow the progression of Alzheimer’s. And there were no differences in the numbers of patients reporting any adverse effects in either the experimental or control groups. A company spokesperson suggests that they are cautiously optimistic…a bit understated we suggest. But it is true that additional studies need to be conducted across more sites to “clarify and confirm its promising biological and clinical effects.” The Chinese equivalent of the FDA has the company’s data under review now at the same time there are plans for more worldwide drug trials soon.
Charlotte Bishop is an Aging Life Care Advisor, Geriatric Care Manager and founder of Creative Care Management, certified professionals who are geriatric advocates, resources, counselors and friends to older adults and their families in metropolitan Chicago. She also is the co-author of How Do I Know You? A Caregiver’s Lifesaver for Dealing with Dementia.