Reversal of Cognitive Decline (ReCODE) Study

NCT ID: NCT03883633

Last Updated: 2021-01-22

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 30 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-06-30
• Study Completion Date: 2020-12-31

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.

Conditions

Alzheimer Disease; Mild Cognitive Impairment

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

Enrolled Participants

All participants enrolled will be tracked from initial assessment to study completion.

ReCODE Protocol

Intervention Type: BEHAVIORAL

Functional medicine approach to address symptoms of Alzheimer's and cognitive decline

Interventions

ReCODE Protocol

Functional medicine approach to address symptoms of Alzheimer's and cognitive decline

Intervention Type: BEHAVIORAL

Other Intervention Names

Bredesen Protocol

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.

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 76 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

QuesGen Systems Inc

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ann Hathaway, MD

Role: PRINCIPAL_INVESTIGATOR

Ann Hathaway MD

Deborah Gordon, MD

Role: PRINCIPAL_INVESTIGATOR

Northwest Memory Center

Kat Toups, MD

Role: PRINCIPAL_INVESTIGATOR

Kat Toups MD

Locations

Ann Hathaway MD

San Rafael, California, United States

Bay Area Wellness

Walnut Creek, California, United States

Northwest Memory Center

Ashland, Oregon, United States

Countries

United States

Other Identifiers

RECODE-1018

Identifier Type: -

Identifier Source: org_study_id