Recruitment, screening, and enrollment
This study recruits in a Midwestern state of the United States. We will recruit using a variety of strategies such as referrals by local Alzheimer’s Association chapter, medical centers, and health care providers, study presentations, advertisement, websites, conference exhibits, and press re- lease. Ninety subjects will be enrolled over a 5-year period using the inclusion/exclusion criteria (Table 1). Respon- dents to our recruitment will undergo a 4-step screening process to qualify for the non-MRI part of the study:
1) Phone screen (5 to 10 minutes) to elicit AD
diagnosis and contraindications to exercise;
2) In-person interview (2 hours) at the CTSI to obtain informed consent/assent and Health Insurance Portability and Accountability Act (HIPAA) and medical record release authorization. Then, two staff will take turns to interview the subject and family caregiver separately. For example, an RA will first interview the subject using the MMSE and health history form, while the study coordinator will interview the family caregiver using the CDR. Afterwards, the RA will interview the caregiver
using the health history form, while the study coordinator will interview the subject using the CDR and conduct a focused neurologic and cardiac physical exam;
3) Medical verification of AD diagnosis, exercise safety, and MRI safety with the subject’s health care providers (1 to 4 weeks). Medical verification letter will be sent if the subject’s CDR is 0.5 to 2 and MMSE is 15 to 26; and
4) Symptom-limited peak cycle-ergometer test (30 to60 minutes) to rule out cardiac ischemia and serious arrhythmia and determine peak heart rate (HR) and maximal oxygen consumption (VO2peak). The test is conducted either by a trained exercise technician, a study staff/RA, and a physician co-investigator, or a trained exercise technician, a study staff/RA, and an allied health professional trained in supervising exercise testing with the physician on call.