2025 Randomized Controlled Trial

The 2025 Randomized Controlled Trial is a randomized, multicenter, controlled clinical trial comparing the efficacy of a precision medicine protocol (based on our ReCODE Protocol™) to the standard of care for treatment of Alzheimer’s. It is the first such trial in which contributors such as biotoxins, oral microbiome, and tick-borne illnesses have been sought and, when identified, treated.

The study was conducted at six sites across the United States with participants ranging in age from 45 to 76. These patients were treated at the stage of mild cognitive impairment or early dementia (the same stages as those treated in trials for the new drugs that target amyloid, i.e., Leqembi and Kisunla).

A peer-reviewed publication is in progress, but the preprint has posted, and we are already learning important lessons from the initial trial data. Here is a summary of some of the key findings from the trial:

1. Our protocol produced statistically significant improvements in memory, executive function, brain processing speed, and overall cognition, whereas the standard of care treatment did not.
2. Cognitive symptoms were markedly improved by our protocol, as noted both by the patients and their partners.
3. Statistically significant improvements in multiple health parameters occurred with our protocol: better blood pressure, body mass index, insulin sensitivity, hemoglobin A1c, lipid profiles (“cholesterol”), and methylation.
4. The overall effect of our protocol was greater than any other treatment for cognitive decline — and 600% better (i.e., 7 times) the effect of Leqembi, the Alzheimer’s drug (you can see this in Figure 10 in the preprint). 

This trial successfully extends Dr. Dale Bredesen’s prior research and validates the Bredesen Protocol, as study participants receiving the precision medicine protocol experienced statistically significant improvements in overall cognitive index, memory scores, executive function, and other cognitive tests.

In particular, participants’ gains in their memory scores were impressive.

In addition, after declining for 9 months on standard-of-care treatment, those patients were offered 6 months on the precision medicine protocol and demonstrated markedly improved cognitive scores at the center, which has completed treatment so far. 

You can read more about the study details here, or get started on your own precision medicine protocol. 

2025 Randomized Controlled Trial in the Press