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.

Conditions

• Mild Cognitive Impairment
• Dementia, Mild

Interventions

DIETARY_SUPPLEMENT

Precision Medicine Approach

Precisions Medicine Approach involves a combination of medicines, dietary supplements, lifestyle changes, and diagnostics

COMBINATION_PRODUCT

Hormones and Medications tailored to lab tests, combined with devices that support stress management and brain exercises

Tailored Medications and Devices to address imbalances per lab results, known to affect cognitive function: Potential Devices: Oura Ring, Continuous Glucose Monitor, Keto-Mojo, and Heartmath Inner Balance. Few may receive Hyperbaric Oxygen Treatment, neurostimulation, neurofeedback, neurostimulation to reduce stress and relax the body), photobiomodulation (light therapy), or CPAP. Atrophic subtype support may include: estradiol, progesterone, testosterone, DHEA, pregnenolone, levothyroxine, liothyronine, hydrocortisone. Bacterial or Viral infection treatment may include: Doxycycline, Minocycline, Nitazoxanide, Hydroxychloroquine, Rifampin, Dapsone, Azithromycin, Tetracycline, Benzathine Penicillin G, Methylene Blue, Nystatin, Clotrimazole, Metronidazole, Valacyclovir, Acyclovir, Famciclovir, Shingles Vaccine Vascular treatments may include: antihypertensives, Ubrelvy, aspirin, Eliquis

BEHAVIORAL

Standard-of-Care

Participate in cognitively stimulating and social activities, exercise, sleep, control risk factors, adhere to a health diet, consult physician if conditions worsen

BEHAVIORAL

Lifestyle including diet, exercise, stress management

Combining a tailored diet, exercise and stress management program supported by coaching specialists

Sponsors & Collaborators

• Four Winds Foundation

  collaborator UNKNOWN

• Alzheimer's Prevention and Reversal Project, Inc.

  lead OTHER

Principal Investigators

• Dale Bredesen, MD · Alzheimer's Prevention and Reversal Project, Inc.

• Kat Toups, MD · Bay Area Wellness

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

45 Years

Max Age

76 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-07-31

Primary Completion

2025-10-31

Completion

2026-02-09

FDA Drug

Yes

Countries

• United States

Study Locations