Clinical trial NCT03883633: Reversal of Cognitive Decline (ReCODE) Study
Official title: Reversal of Cognitive Decline (ReCODE) Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Alzheimer Disease
Mild Cognitive Impairment
Keywords: Dementia
Alzheimer's Disease
Cognitive Decline
MCI
Lead sponsor: QuesGen Systems Inc
Sponsor class: OTHER
First posted: 2019-03-21
Enrollment: 30
Sex: ALL
Minimum age (years): 45
Maximum age (years): 76
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: People who have signs of reduced neurocognitive function

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.

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.

Primary outcomes:
measure: Changes in short-time memory function
timeFrame: Given at enrollment and repeated at three months, six months and nine months after enrollment
measure: Changes in cognitive function
timeFrame: Given at enrollment and repeated at three months, six months and nine months after enrollment
measure: Perceived changes in capability assessed by input from care giver or family member
timeFrame: Given at enrollment and repeated at three months, six months and nine months after enrollment
Secondary outcomes:
Other outcomes:
Locations:
city: San Rafael
country: United States
facility: Ann Hathaway MD
state: California
city: Walnut Creek
country: United States
facility: Bay Area Wellness
state: California
city: Ashland
country: United States
facility: Northwest Memory Center
state: Oregon
Study officials:
affiliation: Ann Hathaway MD
name: Ann Hathaway, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Northwest Memory Center
name: Deborah Gordon, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Kat Toups MD
name: Kat Toups, MD
role: PRINCIPAL_INVESTIGATOR
References: