Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:44 AM
Ignite Modification Date:
2025-12-25 @ 2:44 AM
NCT ID:
NCT03883633
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
45 Years
Maximum Age:
76 Years
Study:
NCT03883633
Study Brief:
Protocol Section:
NCT03883633