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:
2025-12-24 @ 10:52 PM
Ignite Modification Date:
2025-12-24 @ 10:52 PM
NCT ID:
NCT01283269
Eligibility Criteria:
Inclusion Criteria:
* Enrolled as a research participant in the Alzheimer's Disease Research Center with a consensus diagnosis of amnestic Mild Cognitive Impairment (MCI: single domain or multi-domain).
* Has a program partner that has at least twice weekly contact with the participant
* Dementia Rating Scale-2nd Edition (DRS-2) score of 115 or greater
* Functional Ability Questionnaire (FAQ) score below 6.
* Program Partner with Mini Mental State Exam (MMSE) of 24 or greater. (If a program partner has an MMSE less than 24, the site PI will recommend that the person seek further evaluation of cognition through their primary care physician. The person with MCI will be encouraged to find an alternate program partner.)
* Either not taking or stable on nootropic(s) for at least 3 months
* Has English as primary language
Exclusion Criteria:
* Diagnosis other than amnestic MCI (single domain or multi-domain)
* Visual/hearing impairment or history of reading/writing disability sufficient to interfere with training
* Inclusion in another clinical trial that would exclude participation. Subject will be considered for participation at the end of such a trial or as appropriate.
* Baseline score on the self-report depression measure suggesting severe depression for either the participant or the program partner (\>21 on the Centers for Epidemiological Studies - Depression Scale (CES-D) and need for psychiatric treatment. (If a patient or program partner has a CES-D greater than 21, the site Principal Investigator will rule out suicidal ideation and then recommend that the person seek further evaluation of mood from their primary care physician, psychiatrist, or other mental health practitioner. If they seek treatment and have been stable on that treatment for 3 months, they would then be allowed to be reconsidered for the study.)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01283269
Study Brief:
Protocol Section:
NCT01283269