evapearl57 wrote:...My 87-year-old father is in the early stages of Alheimer's, and is starting on the ReCode protocol...I stand by my belief that all the documented improvements and reversals are real, and that trying it is worth the effort and expense -- but am hoping that the kind of clinical trial (that all the nay-sayers claim is the ONLY valid form of evidence) is is the works.
A warm welcome on the first day of a new season of the year, Evapearl57,
I will try to answer your question about clinical trials--as soon as I recognize how much you and your family have already done.
It sounds like your family has strongly come together to support your father through some sad days recently with the loss of your mother and his diagnosis of early-stage Alzheimer's. The practical support in taking over some tasks and the regular social support that you are giving your dad shows that you all recognize his "fervent insistence" as a deeply held value as he ages.
As a 67-year old who has experienced those events with my husband's family and my own, I hope on this first holiday without your mother that you and your siblings reminisce with your father about what he and your mother shared together and gave to you and your siblings. Looking back together can help in looking forward together, even if you have very different perspectives.
One of the ways to find common ground with your siblings is to have a conversation together with him about his values and preferences, and to make a commitment to share the same important information about his care. The Centers for Disease Control and Prevention (CDC) has a wonderful section on Alzheimer's and Healthy Aging which includes this helpful form for overall caregiving information:
Complete Care Plan FormI love that it starts with this suggestion:
In a few sentences, tell people what you want them to know about you. What is your family like? Where did you grow up? What kind of activities do you like doing (walking, sitting by the garden, playing cards, watching a TV show)? What things are you interested in learning about?
It also suggests documents that can be important to have for future planning, such as a Durable Power of Attorney, a Health Care proxy (which can still allow for you to implement Dr. Bredesen's recommendations, even if someone else holds decision-making for hospitalizations, for example), and an Advance Directive.
The question about clinical trials is a great one to talk about as a family, and requires a bit of shared understanding of what is a clinical trial. The National Institute of Health's Clinical Trials website's
What is a Clinical Trial? might be a great way to start, with everyone having a copy to read before a conversation on how each feels. (The website also has a handy tool to find clinical trials.)
In a clinical trial, participants receive specific interventions according to the research plan or protocol created by the investigators...Every clinical study is led by a principal investigator, who is often a medical doctor. Clinical studies also have a research team that may include doctors, nurses, social workers, and other health care professionals.
Clinical studies can be sponsored, or funded, by pharmaceutical companies, academic medical centers, voluntary groups, and other organizations, in addition to Federal agencies such as the National Institutes of Health, the U.S. Department of Defense, and the U.S. Department of Veterans Affairs. Doctors, other health care providers, and other individuals can also sponsor clinical research.
Dr. Bredesen has conducted "clinical studies" of his protocol on participants who agreed to take recommended supplements and follow recommendations for diet, exercise, sleep, etc. He has written about those, both in his book and in a more recent article in an open-access journal:
Reversal of Cognitive Decline: 100 Patients. Here's an excerpt from the "Discussion" section of that article, in which researchers typically summarize the benefits and limitations of a study and future directions:
In the current set of 100 patients, for those evaluated by MoCA, MMSE, or SLUMS pre- and post-treatment (72 of the 100), there was a mean improvement of 4.9 points, with a standard deviation of 2.6 and a range of 1-12. Since the natural history is one of decline, the improvements that were documented must be considered as additional to the prevention of decline that would otherwise have occurred. Of course these numbers must be tempered with any failures that occur, so that it will be important to revise these in the context of a randomized, controlled clinical trial...
As more patients are treated with this approach, patterns of improvement vs. lack of improvement, timing, which domains typically improve and which do not, and related insights are likely to emerge. Although this was not a focus of the cases reported here, certain observations were made repeatedly. One of these was that the significant others of the patients typically reported that the patients were “more engaged” and more responsive with treatment. Facial recognition, navigation, and memory were often improved, whereas calculation and aphasia were less often improved.
It's okay for you to acknowledge their concrn and add your own belief: "I know you would like evidence from a large clinical trial before starting this with our dad. Yet I believe that there is enough preliminary evidence that this protocol may have positive effects, and is unlikely to hurt our father." That shows you respect their concerns and are open to monitoring how he does on the protocol. Your siblings may be more supportive if you focus on certain aspects: the benefit of social engagement and exercise, good sleep, lowering added sugar, optimization of Vitamin B-12 to a level of 500 ng/mL, substituting healthy fats for unhealthy fats. (You can find links to studies of each of these using our
WikiThe protocol doesn't require them or you to sacrifice deeply held beliefs. It merely suggests trying to nudge certain areas in ways that will support his continued fervent goal of independence. If that is the shared goal, it may be easier to acknowledge that many efforts are likely to help him achieve it. Best wishes for a holiday that includes time for celebrating what a great family you have!