Alzheimer Disease, Mild Cognitive Impairment
Conditions
Keywords
Dementia, Alzheimer's Disease, Cognitive Decline, MCI
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.
Interventions
BEHAVIORALReCODE Protocol
Functional medicine approach to address symptoms of Alzheimer's and cognitive decline
Sponsors
QuesGen Systems Inc
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
45 Years to 76 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in short-time memory function | Given at enrollment and repeated at three months, six months and nine months after enrollment | Participants will be given an on-line assessment to test memory and recall using CNS (Central Nervous System) Vitals assessment. |
| Changes in cognitive function | Given at enrollment and repeated at three months, six months and nine months after enrollment | Participants will be evaluated for cognitive capability using the Montreal Cognitive Assessment (MoCA) |
| Perceived changes in capability assessed by input from care giver or family member | Given at enrollment and repeated at three months, six months and nine months after enrollment | Care givers will be surveyed about the participants capability using an assessment based on the Alzheimer's Questionnaire 21-question assessment (AQ-21) |
Countries
United States
Outcome results
None listed