Reversal of Cognitive Decline (ReCODE) Study (RECODE)

January 20, 2021 updated by: QuesGen Systems Inc
Prospective study on patients enrolled in the ReCODE treatment protocol

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Given at enrollment and repeated at three months, six months and nine months after enrollment
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)
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
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)
Given at enrollment and repeated at three months, six months and nine months after enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
QuesGen Systems Inc

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 30, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 13, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 18, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 21, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 22, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 20, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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