Reversal of Cognitive Decline (ReCODE) Study (RECODE)

Prospective study on patients enrolled in the ReCODE treatment protocol

Study Overview

• Status: Completed
• Conditions: Alzheimer Disease; Mild Cognitive Impairment
• Intervention / Treatment: Behavioral: ReCODE 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.

• Study Type: Observational
• Enrollment (Actual): 30

Contacts and Locations

Study Locations

• United States
  • California
    • San Rafael, California, United States, 94903
      • Ann Hathaway MD
    • Walnut Creek, California, United States, 94597
      • Bay Area Wellness
  • Oregon
    • Ashland, Oregon, United States, 97520
      • Northwest Memory Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 76 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

People who have signs of reduced neurocognitive function

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Enrolled Participants; All participants enrolled will be tracked from initial assessment to study completion.	Behavioral: ReCODE Protocol; Functional medicine approach to address symptoms of Alzheimer's and cognitive decline; 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

Collaborators and Investigators

• Sponsor: QuesGen Systems Inc
• Investigators: Principal Investigator: Ann Hathaway, MD, Ann Hathaway MD; Principal Investigator: Deborah Gordon, MD, Northwest Memory Center; Principal Investigator: Kat Toups, MD, Kat Toups MD

Study record dates

Study Major Dates

• Study Start (Actual): June 30, 2019
• Primary Completion (Actual): December 31, 2020
• Study Completion (Actual): December 31, 2020

Study Registration Dates

• First Submitted: March 13, 2019
• First Submitted That Met QC Criteria: March 18, 2019
• First Posted (Actual): March 21, 2019

Study Record Updates

• Last Update Posted (Actual): January 22, 2021
• Last Update Submitted That Met QC Criteria: January 20, 2021
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: Alzheimer's Disease; MCI; Dementia; Cognitive Decline
• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Neurodegenerative Diseases; Dementia; Tauopathies; Cognition Disorders; Alzheimer Disease; Cognitive Dysfunction
• Other Study ID Numbers: RECODE-1018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No