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
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment |
---|---|
Alzheimer Disease Mild Cognitive Impairment | Behavioral: ReCODE Protocol |
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 |

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 |
- 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)

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
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 |
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.

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
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 |
Principal Investigator: | Ann Hathaway, MD | Ann Hathaway MD | |
Principal Investigator: | Deborah Gordon, MD | Northwest Memory Center | |
Principal Investigator: | Kat Toups, MD | Kat Toups MD |
Responsible Party: | QuesGen Systems Inc |
ClinicalTrials.gov Identifier: | NCT03883633 |
Other Study ID Numbers: |
RECODE-1018 |
First Posted: | March 21, 2019 Key Record Dates |
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 |
Dementia Alzheimer's Disease Cognitive Decline MCI |
Alzheimer Disease Cognitive Dysfunction Dementia Brain Diseases Central Nervous System Diseases Nervous System Diseases |
Tauopathies Neurodegenerative Diseases Neurocognitive Disorders Mental Disorders Cognition Disorders |