Phase
Condition
Mild Cognitive Impairment
Alzheimer's Disease
Memory Loss
Treatment
Precision Medicine Approach
Hormones and Medications tailored to lab tests, combined with devices that support stress management and brain exercises
Lifestyle including diet, exercise, stress management
Clinical Study ID
Ages 45-76 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Provide signed informed consent
Adults of any gender, race, or ethnicity and aged 45 to 76 years at time ofenrollment
Cognitive impairment or early-stage dementia as demonstrated by combination of AQ-21score >4 and either:
MoCA 18-26, inclusive, or
greater than or equal 2 scores in the bottom 50th percentilve for NCI or ExecutiveFunction, 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 allaspects of teh protocol and provide input for subjective ratings of theparticipant's cognitive status. The study partner must interact with teh participantfrequently (live with or have daily contact with participant), and have sufficientlyclose relationship to observe and understand participant's difficulties with memorand 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 AndroidSmartphone or tablet capable of connecting to devices and applications used in thestudy
Ability to use a computer and web interface, or have readily available assistance tofacilitate the use of a computer and web interface
Ability to converse with a coach or provider virtually to access the virtualcoaching aspects of the treatment approach
Willing and able to follow the protocol procesured and testing, including changes indiet, lifestyle, supplements, and medications
Willing to have at least one home visit by the study health coach, including homeevaluation for toxins or mold
Willingness to remediate and/or move away from identifies sources of toxicity suchas 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 forat 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 thecourse of the study.
Women who are premenopausal and sexually active must be willing to use appropriatecontraception 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 healthissues detected during these screening exams: 1) Mammogram within 12 months ofrandomization; 2) Pelvic exam within 12 moths for women less than 60 years or pelvicexam within 24 months if 60 years or older.
Exclusion
Exclusion Criteria:
Presence of any uncontrolled major medical illness, seizures, or cardiovasculardisease
Diagnosis of Type 1 Diabetes
Presence of any major psychiatric diagnoses that impact the performance ofactivities of daily living or functioning, other than those related to cognitivedecline
Use of psychoactive medications known to impact cognition, unless willing andeligible to discontinue
Use of chronic anticoagulation therapy, other than prophylactic aspirin orproteolytic enzymes, or a history of recurrent deep vein thrombosis
MRI findings of hydrocephalus, focal stroke, extinsive white matter disease or braintumor
Prior traumatic brain injury of sufficient severity to impact functioning on aregular basis
Diagnosis of cancer in past 5 years, or any history or breast cancer; exclusive ofmelanoma 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 bioidenticalhormone replacement therapy
Positive preganance test
Presence of an existing daignosis of non-Alzheimer's neurodegenerative disorderssuch as Lewy Body Disease, Frontotemporal Disease, Chronic Traumatic Encephalopathy,Korsakoff's Syndrome, etc.
A diagnosis of cerebrovascular disease as the primary cause of cognitive impairmentor 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, ReCODEProgram, or similar methodology such as functional, integrative, or systems medicineat 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
Study Design
Study Description
Connect with a study center
True Health Center for Functional Medicine
Folsom, California 95630
United StatesSite Not Available
Ann Hathaway, MD
San Rafael, California 94903
United StatesSite Not Available
Bay Area Wellness
Walnut Creek, California 94597
United StatesSite Not Available
Rezilir Health
Hollywood, Florida 33020
United StatesSite Not Available
Kemper Cognitive Wellness
Rocky River, Ohio 44116
United StatesSite Not Available
MaxWell Clinic, PLC
Brentwood, Tennessee 37027
United StatesSite Not Available
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