Precision Medicine Approach for Early Dementia & Mild Cognitive Impairment (EVANTHEA)
Mild Cognitive Impairment, Dementia, Mild
About this trial
This is an interventional treatment trial for Mild Cognitive Impairment focused on measuring Mild Cognitive Impairment, Early-stage dementia, Mild dementia, Alzheimers Disease, Short term memory, Mental recall, MCI, Word finding difficulty
Eligibility Criteria
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 domains are invalid at baseline
Sites / Locations
- True Health Center for Functional Medicine
- Ann Hathaway, MD
- Bay Area Wellness
- Rezilir Health
- Kemper Cognitive Wellness
- MaxWell Clinic, PLC
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Group A (Precision Medicine)
Group B (Standard-of-Care)
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.
Standard-of-care treatment will be based on the practice guideline of hte Development, Dissemination, and Implementation Subcommittee of the American Academy of Neurology. Participants in this group will be guided according to the recommendations which include recommending: participation in cognitively and socially-stimulation activities regular exercise ensuring quality sleep including treatment of any sleep apnea control of any modifiable risk factors such as blood pressure, diabetes, cholesterol, and avoidance of tobacco use evaluation by a primary care physician adherence to a healthy and balanced diet consult a neurologist or primary care physician regarding use of medications consult with their primary care physician to identify any worsening conditions