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Reversal of Cognitive Decline (ReCODE) Study (RECODE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03883633
Recruitment Status : Completed
First Posted : March 21, 2019
Last Update Posted : January 22, 2021
Sponsor:
Information provided by (Responsible Party):
QuesGen Systems Inc

Tracking Information
First Submitted Date March 13, 2019
First Posted Date March 21, 2019
Last Update Posted Date January 22, 2021
Actual Study Start Date June 30, 2019
Actual Primary Completion Date December 31, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 24, 2019)
  • 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.
  • 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)
  • 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)
Original Primary Outcome Measures
 (submitted: March 18, 2019)
  • 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
  • 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)
  • 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)
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Reversal of Cognitive Decline (ReCODE) Study
Official Title Reversal of Cognitive Decline (ReCODE) Study
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.
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population People who have signs of reduced neurocognitive function
Condition
  • Alzheimer Disease
  • Mild Cognitive Impairment
Intervention Behavioral: ReCODE Protocol
Functional medicine approach to address symptoms of Alzheimer's and cognitive decline
Other Name: Bredesen Protocol
Study Groups/Cohorts Enrolled Participants
All participants enrolled will be tracked from initial assessment to study completion.
Intervention: Behavioral: ReCODE Protocol
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: March 18, 2019)
30
Original Estimated Enrollment Same as current
Actual Study Completion Date December 31, 2020
Actual Primary Completion Date December 31, 2020   (Final data collection date for primary outcome measure)
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.
Sex/Gender
Sexes Eligible for Study: All
Ages 45 Years to 76 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03883633
Other Study ID Numbers RECODE-1018
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Current Responsible Party QuesGen Systems Inc
Original Responsible Party Same as current
Current Study Sponsor QuesGen Systems Inc
Original Study Sponsor Same as current
Collaborators Not Provided
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
PRS Account QuesGen Systems Inc
Verification Date March 2020