Alzheimer DiseaseRECODENCT03883633
Reversal of Cognitive Decline (ReCODE) Study
An observational study of Alzheimer Disease and Mild Cognitive Impairment, run by QuesGen Systems Inc at 3 sites in United States.
Trial summary
Prospective study on patients enrolled in the ReCODE treatment protocol Read more about this study
- Who is it for?
- Ages 45 to 76 years
- Conditions the study is for
- Alzheimer Disease, Mild Cognitive Impairment
- What is being tested?
- ReCODE Protocol
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 30 participants
- Where
- 3 sitesUnited States
- Study dates
- 30 Jun 2019to 31 Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 76 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: People who have signs of reduced neurocognitive function
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Northwest Memory Center
Ashland, Oregon, 97520
Ann Hathaway MD
San Rafael, California, 94903
Bay Area Wellness
Walnut Creek, California, 94597
About this study
Prospective study on patients enrolled in the ReCODE treatment protocol
Read the 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.
- Conditions
- Alzheimer Disease, Mild Cognitive Impairment
- Being tested
- ReCODE Protocol
- Keywords
- Dementia, Alzheimer's Disease, Cognitive Decline, MCI
- Medical subject headings
- Alzheimer Disease, Cognitive Dysfunction, Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ReCODE ProtocolBehavioural
Also called Bredesen Protocol
Functional medicine approach to address symptoms of Alzheimer's and cognitive decline
| Study group | Role | What they receive |
|---|---|---|
| Enrolled Participants | All participants enrolled will be tracked from initial assessment to study completion. Receives: Behavioral: ReCODE Protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in short-time memory function
Participants will be given an on-line assessment to test memory and recall using CNS (Central Nervous System) Vitals assessment.
Measured: Given at enrollment and repeated at three months, six months and nine months after enrollment
Changes in cognitive function
Participants will be evaluated for cognitive capability using the Montreal Cognitive Assessment (MoCA)
Measured: 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
Care givers will be surveyed about the participants capability using an assessment based on the Alzheimer's Questionnaire 21-question assessment (AQ-21)
Measured: Given at enrollment and repeated at three months, six months and nine months after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2019
- Study start30 Jun 2019
- Primary completion31 Dec 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- QuesGen Systems Inc
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ann Hathaway, MD, Principal investigator, Ann Hathaway MDDeborah Gordon, MD, Principal investigator, Northwest Memory CenterKat Toups, MD, Principal investigator, Kat Toups MD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03883633
- Sponsor's protocol ID
- RECODE-1018
- Acronym
- RECODE
- Status last verified
- Mar 2020
- First submitted
- 13 Mar 2019
- Last updated
- 22 Jan 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reversal of Cognitive Decline (ReCODE) Study
- ClinicalTrials.gov ID
- NCT03883633
- Acronym / sponsor ID
- RECODE / RECODE-1018
- Conditions
- Alzheimer Disease, Mild Cognitive Impairment
- Keywords
- Dementia, Alzheimer's Disease, Cognitive Decline, MCI
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- QuesGen Systems IncUniversity, hospital or other
- Study start
- 30 Jun 2019 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 21 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Enrolled Participants | – | Behavioral: ReCODE ProtocolAll participants enrolled will be tracked from initial assessment to study completion. |
Who may qualify
- Ages
- 45 to 76 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- People who have signs of reduced neurocognitive function
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (16 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ReCODE ProtocolAlso: Bredesen ProtocolFunctional medicine approach to address symptoms of Alzheimer's and cognitive decline | Behavioural | Enrolled Participants |
Primary outcome
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ann Hathaway, MD principal investigator
Ann Hathaway MD
Deborah Gordon, MD principal investigator
Northwest Memory Center
Kat Toups, MD principal investigator
Kat Toups MD
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Alzheimer Disease and Mild Cognitive Impairment, run by QuesGen Systems Inc at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in short-time memory function (time frame: Given at enrollment and repeated at three months, six months and nine months after enrollment). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2021.