Reversal of Cognitive Decline (ReCODE) Study (RECODE)

• ClinicalTrials.gov Identifier: NCT03883633
• Recruitment Status: Completed
• First Posted: March 21, 2019
• Last Update Posted: January 22, 2021
• Sponsor: QuesGen Systems Inc
• Information provided by (Responsible Party): QuesGen Systems Inc

Study Description

Brief Summary:

Prospective study on patients enrolled in the ReCODE treatment protocol

Condition or disease	Intervention/treatment
Alzheimer Disease; Mild Cognitive Impairment	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 Design

• Study Type: Observational
• Actual Enrollment: 30 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• Official Title: Reversal of Cognitive Decline (ReCODE) Study
• Actual Study Start Date: June 30, 2019
• Actual Primary Completion Date: December 31, 2020
• Actual Study Completion Date: December 31, 2020

Groups and Cohorts

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 Name: Bredesen Protocol

Outcome Measures

Primary Outcome Measures :

1. Changes in short-time memory function [ Time Frame: 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.
2. Changes in cognitive function [ Time Frame: 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)
3. Perceived changes in capability assessed by input from care giver or family member [ Time Frame: 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)

Eligibility Criteria

• Ages Eligible for Study: 45 Years to 76 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Non-Probability Sample

Study Population

People who have signs of reduced neurocognitive function

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.

Contacts and Locations

Locations

United States, California

Ann Hathaway MD

San Rafael, California, United States, 94903

Bay Area Wellness

Walnut Creek, California, United States, 94597

United States, Oregon

Northwest Memory Center

Ashland, Oregon, United States, 97520

Sponsors and Collaborators

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

More Information

• Responsible Party: QuesGen Systems Inc
• ClinicalTrials.gov Identifier: NCT03883633
• Other Study ID Numbers: RECODE-1018
• First Posted: March 21, 2019
• Last Update Posted: January 22, 2021
• Last Verified: March 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by QuesGen Systems Inc:

Dementia; Alzheimer's Disease; Cognitive Decline; MCI

Additional relevant MeSH terms:

Alzheimer Disease; Cognitive Dysfunction; Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Cognition Disorders