Tuesday, July 16, 2019

Positive Studies Offer Limited Hope

Dimensions of Dementia

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My first Dimensions of Dementia column appeared in April 2016. Since then I’ve written monthly on numerous subjects including types of dementia, dementia-care experts, facilities and research. I thought about possible subjects for this month’s column, which is to be my last. It will be my last, not because I’ve lost my interest in advocacy for dementia caregivers and care receivers, but because I’m giving up having to meet a monthly deadline. In a period of transition, I’ll be moving soon to an over-55 retirement community in North Naples, taking my own advice to think ahead and plan for future needs.

What I decided to write about is whether there has been any progress in stopping or slowing the decline of one’s brain from Alzheimer’s disease. We still don’t have a vaccine or magic pill to prevent Alzheimer’s disease and other dementias. But what we do have, I believe, is a number of promising advances towards slowing the onset of dementia and reducing the severity of the brain’s decline.

For example, an article, “Results of Research Study Show Statistically Significant Slowing of AD Progression,” in the Summer 2018 issue of the University of Pittsburgh’s Alzheimer’s Disease Research Center’s newsletter, ADRC Pathways, relates hopeful news. It summarizes results of a Phase II study of a new drug, BAN2401 announced by two pharmaceutical companies. “The study demonstrated statistically significant slowing of Alzheimer’s disease (AD) progression, as measured by cognitive tests, and reduction of amyloid beta accumulated in the brain, as measured by PET scans.” This is really positive news but you may be thinking as I am, we’ve heard promising news about research studies before only to have failure in later tests.

The study was conducted in 856 patients with early onset AD who were followed for a period of 18 months. The article states, “the drug was well tolerated, and as expected, one of the most frequent side effects was the incidence of areas of inflammation in the brain detected by an MRI. Not more than ten percent of study subjects who received the treatment were affected. It’s important to note that this is the first Phase II study in many years that has successfully demonstrated disease-modifying effects on both clinical function and amyloid beta accumulation in the brain.” The final results will come from a large Phase III study required by the FDA to obtain regulatory approval when the new drug can be made available to the public.

A New York Times article of July 25, 2018, “New Alzheimer’s Drug Slows Memory Loss in Early Trial Results,” about the same study yields more details. It called the study’s findings a “potentially promising milestone.” The results of the trial were presented at the Alzheimer’s Association International Conference in Chicago: “Many other drugs have managed to reduce amyloid levels but they did not ease memory decline or other cognitive difficulties. The highest of the five doses of BAN2401 — an injection every two weeks of 10 milligrams per kilogram of a patient’s weight both reduced amyloid levels and slowed cognitive decline when compared to patients who received placebo. Of 161 patients in the group taking the highest dose, 81 percent showed such significant drops in amyloid levels that they converted from amyloid positive to amyloid negative,” according to Dr. Lynn Kramer, chief medical officer for Eisai, the Japan-based company who developed the drug along with Biogen of Cambridge, Massachusetts.

“On a battery of cognitive and functional tests measuring memory and skills like planning and reasoning, the performance of the high-dose group declined at a rate that was 30 percent slower than the rate of decline in the placebo group.”

The New York Times article includes the information that Eisai is the maker of Aricept, one of the few drugs that can help slow early memory decline while Biogen is the maker of another Alzheimer’s treatment, aducanumab, that has shown early promise in a small Phase I trial in both reducing amyloid and slowing cognitive decline. The outcome of two large clinical trials of this drug is expected to be available in 2020.

Results of a small study were also announced at the Alzheimer’s Association International Conference and reported in the Washington Post article of September 10, 2018, “Synthetic Marijuana and Brighter Lights Could Improve the Lives of People with Dementia, New Research Shows.” The study from the University of Toronto found, “a synthetic form of tetrahydrocannabinol (THC) the active chemical in marijuana, was found to be safe and effective in treating agitation, lack of appetite and other behavioral symptoms in dementia patients.”

In the trial, 39 people with moderate to severe Alzheimer’s dementia received nabilone, a synthetic form of THC that is easier to regulate and is available in capsule form, for six weeks and a placebo for six weeks. While on nabilone, their agitation levels and neuropsychiatric symptoms were reduced while their appetites improved, as exhibited in clinical tests and caregiver reports but currently, the FDA has not approved any drug use for these symptoms in the United States according to the article.

Positive results can come from very small studies too. Ohio State University’s Wexner Medical Center conducted a study aimed at slowing the decline of problem-solving and decision -making skills in dementia patients. Thin electrical wires were surgically implanted into the frontal lobes of the patient’s brains to determine if using a brain pacemaker could improve their cognitive, behavioral, and functional abilities. According to the online article of August 18, 2018 from the Alzheimer’s Reading Room, this very small pilot study of three Alzheimer’s patients found, “deep brain stimulation targeting frontal brain regions can reduce the overall performance decline typically seen in people with mild Alzheimer’s disease.” “All three study participants showed improvement, including LaVonne Moore, 85, of Delaware, Ohio. Not doing any meal preparation when she entered the study, after two years of deep-brain stimulation, she could independently initiate preparations of a simple meal, assemble ingredients and cook the meal.”

There is also much agreement from experts working in the dementia field that regular exercise, a Mediterranean diet low in sugar and unhealthy fats, high in greens, vegetables, fish and healthy fats that includes a lifestyle of social engagement and stimulation of the brain gives positive results. Dr. David Perlmutter, neurologist who practiced in Naples, Florida, is an author and one of the advocates for ways to keep the body and brain healthy. His recommendations can be accessed at drperlmutter.com where you can sign up for his online newsletter. He with other medical experts shared their wisdom during a recent free online series titled Regain Your Brain.

All of these small advances give me hope that not only will a drug or vaccine be available soon to prevent dementia with its loss of reasoning and memory but also that a healthy diet and regular exercise will be included in every prescription to optimize brain health.

Thank you for reading my columns and for giving me encouragement and positive feedback about them. I feel privileged to have shared the time with you.

We are very fortunate in this area to have organizations to help us when coping with any dementia, the Alzheimer’s Association and the local Alzheimer’s Support Network. Their contact information can be found at the end of this column. Also, the Naples Senior Center provides dementia-respite care on Marco Island and in Naples locations. Contact them at 239-325-4444. There are also many online sources for information about caregiving and the various dementias. Please check them out for new information to help you and those you care for live a healthy, positive life.

Shirley Woolaway has an M. Ed. in counseling and worked in journalism, in business, and as a therapist in Pennsylvania. She has 25 years personal experience with dementia as a caregiver for family members with Alzheimer’s disease, and 11 years as the coordinator of an Alzheimer’s Association memory loss/caregiver support group, earlier in Pennsylvania and now on Marco Island.

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