Precision Medicine Approach for Early Dementia & Mild Cognitive Impairment
Summary
The goal of this clinical trial is to compare a precision medicine approach to the standard-of-care for people with mild cognitive impairment or early-stage dementia. Precision medicine approach starts with the completion of many tests and then the study doctor uses the test results to carefully prepare a treatment plan that is best for the individual person to help treat many of the underlying causes of mild cognitive impairment or early-stage dementia. The main question the study aims to answer is: • Does the precision medicine approach improve memory (cognitive function) better than the current standard-of-care treatment in people with mild cognitive impairment or early-stage dementia during a 9-month treatment period? This is a randomized clinical trial which means that a group of people that meet the study requirements will be assigned at random or by chance (like toss of a coin) to receive either the precision medicine treatment or the current gold standard (standard-of-care). People assigned to the precision medicine group will receive precision medicine for 9-months while those assigned to the standard-of-care group will follow that approach for 9-months, followed by an opportunity to receive up to six months of precision medicine, if desired. Participants will be asked to: * Have their blood drawn for extensive lab testing and collect urine and stool samples as well * Carefully follow instructions received from their study doctor and study team * Make lifestyle changes as prescribed by the study doctor and study team based on your precision medicine program * Take supplements and medications prescribed by the study doctor. * Once officially in the study (after meeting study entry or screening requirements), participate in ten (10) monthly visits with the study doctor, and other members of the study team as scheduled. * Complete cognitive tests at scheduled visits during the study * Have a study partner with you during visits and to help support you on the program Researchers will compare test results between the two study groups to see if the precision medicine approach improves those tests results over the time of the study, resulting in the improvement of cognition over a 9-month treatment period.
Timeline
- Start
- 2023-07-31
- Primary completion
- 2025-10-31
- Completion
- 2026-02-09
Publications
- Background Toups K, Hathaway A, Gordon D, Chung H, Raji C, Boyd A, Hill BD, Hausman-Cohen S, Attarha M, Chwa WJ, Jarrett M, Bredesen DE. Precision Medicine Approach to Alzheimer's Disease: Successful Pilot Project. J Alzheimers Dis. 2022;88(4):1411-1421. doi: 10.3233/JAD-215707.
- Background Bredesen DE, Amos EC, Canick J, Ackerley M, Raji C, Fiala M, Ahdidan J. Reversal of cognitive decline in Alzheimer's disease. Aging (Albany NY). 2016 Jun;8(6):1250-8. doi: 10.18632/aging.100981.
- Background Rao RV, Kumar S, Gregory J, Coward C, Okada S, Lipa W, Kelly L, Bredesen DE. ReCODE: A Personalized, Targeted, Multi-Factorial Therapeutic Program for Reversal of Cognitive Decline. Biomedicines. 2021 Sep 29;9(10):1348. doi: 10.3390/biomedicines9101348.
- Background Bredesen DE. Reversal of cognitive decline: a novel therapeutic program. Aging (Albany NY). 2014 Sep;6(9):707-17. doi: 10.18632/aging.100690.
- Background McMaster M, Kim S, Clare L, Torres SJ, D'Este C, Anstey KJ. Body, Brain, Life for Cognitive Decline (BBL-CD): protocol for a multidomain dementia risk reduction randomized controlled trial for subjective cognitive decline and mild cognitive impairment. Clin Interv Aging. 2018 Nov 21;13:2397-2406. doi: 10.2147/CIA.S182046. eCollection 2018.
- Background Ross MK, Raji C, Lokken KL, Bredesen DE, Roach JC, Funk CC, Price N, Rappaport N, Hood L, Heath JR. Case Study: A Precision Medicine Approach to Multifactorial Dementia and Alzheimer's Disease. J Alzheimers Dis Parkinsonism. 2021;11(Suppl 5):018. Epub 2021 Aug 25.
- Background Shetty P, Youngberg W. Clinical Lifestyle Medicine Strategies for Preventing and Reversing Memory Loss in Alzheimer's. Am J Lifestyle Med. 2018 May 11;12(5):391-395. doi: 10.1177/1559827618766468. eCollection 2018 Sep-Oct.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Background | Acyclovir | Small molecule | — | — |
| Background | Apixaban | Small molecule | — | — |
| Background | Aspirin | Small molecule | — | — |
| Background | Azithromycin | Small molecule | — | — |
| Background | Benzathine Penicillin G | Unknown | — | — |
| Background | Clotrimazole | Unknown | — | — |
| Background | DHEA | Unknown | — | — |
| Background | Dapsone | Small molecule | — | — |
| Background | Doxycycline | Small molecule | — | — |
| Background | Estradiol | Other / unclassified | — | — |
| Background | Famciclovir | Small molecule | — | — |
| Background | Hydrocortisone | Other / unclassified | — | — |
| Background | Hydroxychloroquine | Small molecule | — | — |
| Background | Levothyroxine | Other / unclassified | — | — |
| Background | Liothyronine | Unknown | — | — |
| Background | Methylene Blue | Diagnostic / imaging agent | — | — |
| Background | Metronidazole | Small molecule | — | — |
| Background | Minocycline | Small molecule | — | — |
| Background | Nitazoxanide | Other / unclassified | — | — |
| Background | Nystatin | Unknown | — | — |
| Background | Pregnenolone | Other / unclassified | — | — |
| Background | Progesterone | Other / unclassified | — | — |
| Background | Rifampicin | Small molecule | — | — |
| Background | Shingles Vaccine | Vaccine | — | — |
| Background | Testosterone | Small molecule | — | — |
| Background | Tetracycline | Unknown | — | — |
| Background | Ubrogepant | Small molecule | — | — |
| Background | Valacyclovir | Unknown | — | — |