Reversal of Cognitive Decline (ReCODE) Study

NCT03883633 | Completed DMC

• 1 other identifier: RECODE-1018
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 3

Brief Summary

Prospective study on patients enrolled in the ReCODE treatment protocol

Conditions

Alzheimer Disease; Mild Cognitive Impairment

Keywords

Dementia; Alzheimer's Disease; Cognitive Decline; MCI

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (1)

Enrolled Participants

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

Behavioral: ReCODE Protocol

Interventions

ReCODE Protocol BEHAVIORAL

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

Also known as: Bredesen Protocol

Enrolled Participants

Eligibility Criteria

• Age: 45 Years - 76 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

People who have signs of reduced neurocognitive function

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• QuesGen Systems Inc: lead

Study Sites (3)

Ann Hathaway MD

San Rafael, California, 94903, United States

Location

Bay Area Wellness

Walnut Creek, California, 94597, United States

Location

Northwest Memory Center

Ashland, Oregon, 97520, United States

Location

MeSH Terms

Conditions

Alzheimer Disease; Cognitive Dysfunction; Dementia

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Cognition Disorders

Study Officials

• Ann Hathaway, MD

  Ann Hathaway MD

  PRINCIPAL INVESTIGATOR

• Deborah Gordon, MD

  Northwest Memory Center

  PRINCIPAL INVESTIGATOR

• Kat Toups, MD

  Kat Toups MD

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 13, 2019
• First Posted: March 21, 2019
• Study Start: June 30, 2019
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: January 22, 2021

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)