Reversal of Cognitive Decline (ReCODE) Study

Study Overview
=================
Brief Summary
-----------------
Prospective study on patients enrolled in the ReCODE treatment protocol

Detailed Description
-----------------
The objective of the study is to determine if the ReCODE treatment has a measurable impact on the typical progression of neurocognitive decline observed in patients with Alzheimer's Disease (AD) and patients who are exhibiting Mild Cognitive Impairment (MCI). MCI is often a precursor to an AD diagnosis. For this study, there will be no distinction made between participants who have been diagnosed with AD and those who show signs of MCI.

Official Title
-----------------
Reversal of Cognitive Decline (ReCODE) Study

Conditions
-----------------
Alzheimer Disease, Mild Cognitive Impairment

Intervention / Treatment
-----------------
* Behavioral: ReCODE Protocol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 45 to 76 years old Adults of any gender, race or ethnicity Subjects must have cognitive impairment as demonstrated by a combination of AQ-21 over 5 and either a MOCA 26 or below or a CNS Vitals screening assessment in the MCI in the bottom 70th percentile or 2 of the subtests in the bottom 50th percentile. Proficient in spoken and written English for consenting as well as for study participation. Must be able to use a computer and web interface. If assistance is needed, it must be readily available to them. Regular access to a computer and an internet connection since certain aspects of the program (e.g. cognitive training) are delivered electronically Willing and able to follow the protocol if the treating physician determines that is required for appropriate patient care. Exclusion Criteria: Uncontrolled major medical illness, seizures, cardiovascular or cerebrovascular instability. A major psychiatric diagnosis that affects activities of daily living (ADL) or functioning. Currently taking psychoactive medications known to impact cognition. Use of statin therapy, unless eligible to discontinue. Use of anticoagulation therapy or history of deep vein thrombosis. MRI findings of hydrocephalus, focal stroke, extensive white matter disease or brain tumor. Experienced Traumatic Brain Injury (TBI) that is severe enough that it has an ongoing impact on patient function on a regular basis. Lack of support (either family member or caregiver) to assist with following the treatment protocol. Active cancer, cancer within the past five years or any history of breast cancer. Inability to exercise. Inability to use a computer, or no computer access. Unwillingness or ineligibility to use bioidentical hormone replacement. Pregnancy or any chance of becoming pregnant during the course of the study period. Presence of an existing diagnosis of a non-AD neurodegenerative disorder (e.g., Lewy Body Disease, Frontotemporal Disease, Chronic Traumatic Encephalopathy, Korsakoff's Syndrome). Diagnosis of cerebrovascular disease as the primary cause of cognitive impairment. Previous treatment or experience with ReCODE.

Ages Eligible for Study
-----------------
Minimum Age: 45 Years
Maximum Age: 76 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Enrolled Participants<br>All participants enrolled will be tracked from initial assessment to study completion. | Behavioral: ReCODE Protocol<br>* Functional medicine approach to address symptoms of Alzheimer's and cognitive decline<br>* Other names: Bredesen Protocol;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in short-time memory function | Participants will be given an on-line assessment to test memory and recall using CNS (Central Nervous System) Vitals assessment. | Given at enrollment and repeated at three months, six months and nine months after enrollment | 
| Changes in cognitive function | Participants will be evaluated for cognitive capability using the Montreal Cognitive Assessment (MoCA) | Given at enrollment and repeated at three months, six months and nine months after enrollment | 
| Perceived changes in capability assessed by input from care giver or family member | Care givers will be surveyed about the participants capability using an assessment based on the Alzheimer's Questionnaire 21-question assessment (AQ-21) | Given at enrollment and repeated at three months, six months and nine months after enrollment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Dementia, Alzheimer's Disease, Cognitive Decline, MCI