Clinical trial · Interventional
Precision Medicine Approach for Early Dementia & Mild Cognitive Impairment
EVANTHEA TRIAL: A Pragmatic, Randomized, Controlled Trial to Evaluate the Effectiveness of a Precision Medicine Treatment Approach for Early Dementia and Mild Cognitive Impairment
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Dementia, Mild | — | UNRESOLVED | — |
| Mild Cognitive Impairment | — | UNRESOLVED | — |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Hormones and Medications tailored to lab tests, combined with devices that support stress management and brain exercises | Combination Product | — | UNRESOLVED |
| Lifestyle including diet, exercise, stress management | Behavioral | — | UNRESOLVED |
| Precision Medicine Approach | Dietary Supplement | — | UNRESOLVED |
| Standard-of-Care | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Group A (Precision Medicine)
- description
- Precision Medicine approach starts with a battery of tests and questionnaires to determine a person's underlying causes of cognition impairment. A custom treatment program is developed and prescribed by the investigator based on the test results and includes a combination of: supplements, medications, hormone therapy, dietary changes, exercise program, brain exercises, stress management, sleep tracking. Additional treatments may include QEEG and photobiomodulation, neurostimulation, neurofeedback and/or hyperbaric oxygen treatment (additional treatment are only available at select sites). Participants in this Group will also be supported in their program by a nutritionist, health coach, and fitness trainer, in addition to the study doctor. Tracking of study activities may also be required in the form of diaries, and devices will be used to track some of their activities such as sleep, stress, diet and exercise.
- interventionNames
- Dietary Supplement: Precision Medicine Approach
- Combination Product: Hormones and Medications tailored to lab tests, combined with devices that support stress management and brain exercises
- Behavioral: Lifestyle including diet, exercise, stress management
- type
- ACTIVE_COMPARATOR
- label
- Group B (Standard-of-Care)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 45 Years
- Maximum age
- 76 Years
Show eligibility criteria text
Inclusion Criteria: * Provide signed informed consent * Adults of any gender, race, or ethnicity and aged 45 to 76 years at time of enrollment * Cognitive impairment or early-stage dementia as demonstrated by combination of AQ-21 score \>4 and either: * MoCA 18-26, inclusive, or * greater than or equal 2 scores in the bottom 50th percentilve for NCI or Executive Function, Verbal, Visual, or Composite sub-tests * Proficient in spoken and written English for informed consent and study procedures * Have a willing and able study partner to support participant with compliance and all aspects of teh protocol and provide input for subjective ratings of the participant's cognitive status. The study partner must interact with teh participant frequently (live with or have daily contact with participant), and have sufficiently close relationship to observe and understand participant's difficulties with memor and activities of daily living. * All exisiting medical conditions and any current medication dosages must be stable * Have regular access to computer and internet connection and an iOS or Android Smartphone or tablet capable of connecting to devices and applications used in the study * Ability to use a computer and web interface, or have readily available assistance to facilitate the use of a computer and web interface * Ability to converse with a coach or provider virtually to access the virtual coaching aspects of the treatment approach * Willing and able to follow the protocol procesured and testing, including changes in diet, lifestyle, supplements, and medications * Willing to have at least one home visit by the study health coach, including home evaluation for toxins or mold * Willingness to remediate and/or move away from identifies sources of toxicity such as molds or other toxins or infections or dental decay * Willingness to comply with COVID prevention precautions * Participants taking Aricept will be considered if they have been using Aricept for at least 90 days prior to study adminission. Must be on a stable dose for at least 90-days prior to screening and agree to remian on the same dose throughout the course of the study. * Women who are premenopausal and sexually active must be willing to use appropriate contraception and have repeated pregnancy tests as indicated * Willing to have an MRI and coronary artery calcium scan * Live within 1-1.5 hours of the study site * Women only: willing to complete the health screening exams and remediate any health issues detected during these screening exams: 1) Mammogram within 12 months of randomization; 2) Pelvic exam within 12 moths for women less than 60 years or pelvic exam within 24 months if 60 years or older. Exclusion Criteria: * Presence of any uncontrolled major medical illness, seizures, or cardiovascular disease * Diagnosis of Type 1 Diabetes * Presence of any major psychiatric diagnoses that impact the performance of activities of daily living or functioning, other than those related to cognitive decline * Use of psychoactive medications known to impact cognition, unless willing and eligible to discontinue * Use of chronic anticoagulation therapy, other than prophylactic aspirin or proteolytic enzymes, or a history of recurrent deep vein thrombosis * MRI findings of hydrocephalus, focal stroke, extinsive white matter disease or brain tumor * Prior traumatic brain injury of sufficient severity to impact functioning on a regular basis * Diagnosis of cancer in past 5 years, or any history or breast cancer; exclusive of melanoma skin cancers or ductal carcinoma in situ. * Positive test for HIV, Hepatitis C, or RPR (rapid plasma reagin) * Menopausal and perimenopausal women who are unwilling or unable to use bioidentical hormone replacement therapy * Positive preganance test * Presence of an existing daignosis of non-Alzheimer's neurodegenerative disorders such as Lewy Body Disease, Frontotemporal Disease, Chronic Traumatic Encephalopathy, Korsakoff's Syndrome, etc. * A diagnosis of cerebrovascular disease as the primary cause of cognitive impairment or early-stage dementia * Lack of adequate support from a study partner to assist with study adherence * Inability to exercise * Inabilty to use a computer with or without assistance; or no computer access * Plans to travel or be away from home for more than 2 weeks during the course of the 9-month study * Previous treatment using dietary changes, comprehensive nutritional support, ReCODE Program, or similar methodology such as functional, integrative, or systems medicine at a level considered by the investigator to interfere with the study goals * Any contraindication to enclosed MRI * Unwilling or unable to comply with general study procedures * Current user of tobacco * Unwilling or unable to remediate or move away from identified sources of toxicities (molds, toxins, infections, dental decay) * Use of Aricept off-label * Two or more CNS-Vital Sign tests are invalid at baseline
References
Publications (7)
- BACKGROUNDToups 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. PMID 35811518
- BACKGROUNDBredesen 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. PMID 27294343
- BACKGROUNDRao 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. PMID 34680464
- BACKGROUNDBredesen DE. Reversal of cognitive decline: a novel therapeutic program. Aging (Albany NY). 2014 Sep;6(9):707-17. doi: 10.18632/aging.100690. PMID 25324467
- BACKGROUNDMcMaster 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. PMID 30538436
- BACKGROUNDRoss 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. PMID 35237464
- BACKGROUNDShetty 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.