This is the most preliminary evidence possible. Just a couple of case studies. It'll be interesting to see how this pans out with larger trials but there are plenty of Alzheimer drugs that have had far more evidence for their effectiveness then this regimen, and ultimately failed to make any meaningful difference.
Yes they accept that large trials are obviously needed.
> The results suggest that memory loss may be reversed and improvement sustained with the therapeutic program, but Bredesen cautioned that the results need to be replicated.
> “The current, anecdotal results require a larger trial, not only to confirm or refute the results reported here, but also to address key questions raised, such as the degree of improvement that can be achieved routinely, how late in the course of cognitive decline reversal can be effected, whether such an approach may be effective in patients with familial Alzheimer’s disease, and last, how long improvement can be sustained,” he said.
There are no more published results. In interviews Dr Bredesen confirms that the patients after 4 years on the protocol still are without Alzheimer.
One more anecdotal story: one patient did not like the protocol and stopped, Alzheimer returned, started the protocol again, Alzheimer reversed. This happened various times with the same patient. Make your own conclusions/assumptions.
There is a new study with ~100 patients but is is not yet finished.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4221920/