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 @ 3:28 PM
Ignite Modification Date:
2025-12-24 @ 3:28 PM
NCT ID:
NCT01311492
Eligibility Criteria:
Inclusion Criteria:
* 65 years and older
* must be planning to reside in the area for 1 year
* summary scor of greater than or equal to 3 on the Short Physical Performance Battery (SPPB)
* have mild to moderate AD defined by a score of 12-24 on the Mini-Mental Status Examination (MMSE). Diagnosis of probable AD from site physician utilizing the following criteria: Diagnostic and Statistical Manual of Mental Disorders-Fourth Edition (DSM-IV) criteria for Dementia of Alzheimer's Type, National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer's Disease and Related Disorders Association (NINCDS/ADRDA) Criteria for Probable Alzheimer's Disease, and Hachinski Ischemic Score is less than or equal to 4
* sedentary lifestyle which is operationally defined as spending less than 20 minutes a week in the past month getting regular physical activity.
* must be willing to give informed consent, be willing to be randomized to either physical activity or health lifestyle intervention, and to follow the protocol for the group to which they have been assigned
Exclusion Criteria:
* unable or unwilling to give informed consent or accept randomization in either study group
* current diagnosis of schizophreniz, other psychotic disorders, or bipolar disorder
* current consumption of more than 14 alcoholic drinks per week
* plans to relocate to out of the study area within the next year or plans to be out of the study area for more than 6 weeks in the next year
* score of greater than 3 on SPPB
* another member of the household is a participant in they study
* residence too far from the intervention site
* difficulty in communication with study personnel due to speech or hearing problems
* MMSE less than 12 or greater than 24
* currently enrolled in another randomized trial involving lifestyle or phamaceutical interventions
* other medical, psychiatric, or behavioral factors that in the judgement of the Principal Investigator may interfere with study participation or the ability to follow the intervention protocol
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
65 Years
Study:
NCT01311492
Study Brief:
Protocol Section:
NCT01311492