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 @ 12:32 AM
Ignite Modification Date:
2025-12-25 @ 12:32 AM
NCT ID:
NCT00546767
Eligibility Criteria:
Inclusion Criteria:
* Age 75 and older
* Willing to sign consent
* Willing to take multi-vitamins provided by the study
* Minimal computer skills or willingness to learn (as demonstrated by completion during screening of a demonstration module for each arm)
* English fluency
* MMSE greater than 26
* Able to answer and dial a telephone
* Able to complete the in-person assessment
* Able to complete the computerized assessment including adequate speech, hearing and vision
* Independently living adults, defined as living in a setting in which the participant can ensure access to the resources for study procedures
* Participation of a study partner is desirable and encouraged, but not required
Exclusion Criteria:
* Dementia
* Use of prescription cognitive-enhancing drugs at entry (e.g. Aricept, Razadyne, Exelon, Namenda)
* Intent to continue use of own multi-vitamins (for the duration of the study participants must agree to take only study-distributed multi-vitamins)
* History or presence of major psychiatric, neurological or neurodegenerative conditions associated with significant cognitive impairment such as major stroke, Parkinson's disease, Multiple Sclerosis or Huntington's disease. Transient Ischemic Attack (TIA) is acceptable if over 6 months ago
* Medical conditions associated with life expectancy of less than 5 years
* Transient domicile interfering with ability to collect study-related data
* Current participation in a clinical trial involving Central Nervous System (CNS) medications or cognitive testing that would interfere with the current protocol (participation in Uniform Data Set (UDS) assessments by an ADC is permitted)
* Cohabitation with another participant in this particular study
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
75 Years
Study:
NCT00546767
Study Brief:
Protocol Section:
NCT00546767