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Reversal of Cognitive Decline (ReCODE) Study (RECODE)

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ClinicalTrials.gov Identifier: NCT03883633
Recruitment Status : Recruiting
First Posted : March 21, 2019
Last Update Posted : June 26, 2019
Sponsor:
Information provided by (Responsible Party):
QuesGen Systems Inc

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.

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

Resource links provided by the National Library of Medicine


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




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)



Information from the National Library of Medicine

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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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03883633


Contacts
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Contact: Michael Jarrett 4157388452 mike.jarrett@quesgen.com
Contact: Martin Jorgensen 6507777617 martin.jorgensen@quesgen.com

Locations
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United States, California
Ann Hathaway MD Recruiting
San Rafael, California, United States, 94903
Contact: Ann Hathaway, MD    415-499-0966    ahmd@AnnHathawayMD.com   
Bay Area Wellness Recruiting
Walnut Creek, California, United States, 94597
Contact: Kat Toups, MD    925-265-2300    info@bayareawellness.net   
United States, Oregon
Northwest Memory Center Recruiting
Ashland, Oregon, United States, 97520
Contact: Deborah Gordon, MD    541-482-8333    deborah@drdeborahmd.com   
Sponsors and Collaborators
QuesGen Systems Inc
Investigators
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Principal Investigator: Ann Hathaway, MD Ann Hathaway MD
Principal Investigator: Deborah Gordon, MD Northwest Memory Center
Principal Investigator: Kat Toups, MD Kat Toups MD

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Responsible Party: QuesGen Systems Inc
ClinicalTrials.gov Identifier: NCT03883633     History of Changes
Other Study ID Numbers: RECODE-1018
First Posted: March 21, 2019    Key Record Dates
Last Update Posted: June 26, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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