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Using Connectomics to Characterize Risks for Alzheimer's Disease

Start: October 17, 2017
End: October 17, 2022
Enrollment: 296

What Is This Study About?

This observational study will use neuroimaging to understand how the connections in the brain change in healthy aging, mild cognitive impairment (MCI), and Alzheimer's disease in order to assess the risk for developing Alzheimer's. Participants will undergo cognitive testing and PET and MRI scans during four to five site visits over a one-year period.

Do I Qualify To Participate in This Study?

Minimum Age: 45 Years

Maximum Age: 85 Years

Must have:

Participants with Alzheimer's Disease

  • Meet criteria for probable or possible Alzheimer's disease dementia as determined by a qualified provider (e.g.,  neurologist, geriatrician, psychiatrist, or clinician)
  • Mini-Mental State Examination score of 20 to 26 and/or a Clinical Dementia Rating (CDR)-Global score of 1
  • If taking Alzheimer's medications, must be on stable dose for at least two months

Participants with Mild Cognitive Impairment

  • Meet criteria for MCI due to Alzheimer's or mild Alzheimer's disease as determined by a qualified provider (e.g.,  neurologist, geriatrician, psychiatrist, or clinician)
  • Mini-Mental State Examination score of 20 to 30 and/or a CDR-Global score of 0.5

Participants Who Are Cognitively Normal

  • Matched to participants in other groups by age, gender, education, and APOE genotype
  • CDR-Global Score of 0

All Participants

  • APOE 33 or APOE 44 genotype

Must NOT have:

  • If female, must not be pregnant
  • History of psychosis or bipolar disorder
  • History of alcohol or substance abuse in last six months and/or dependence within past five years
  • History of head trauma associated with injury-onset cognitive complaints
  • History of a significant medical condition known to affect cognition (e.g., stroke, brain cancer, head injury, developmental disorder, significant heart disease, or neurosurgical procedures) or current medical condition that is poorly controlled and considered a significant contributor to cognitive status
  • Magnetic resonance imaging (MRI)-related exclusions: metal implants, orthodontics, permanent makeup or tattoos on or near the head, claustrophobia
  • Current serious or clinically significant and/or unstable illness, including heart, liver, kidney, stomach, lung, endocrinologic, brain (other than MCI and Alzheimer's), psychiatric, immunologic, and blood disease or other condition that could interfere with safety and study analyses
  • Received an investigational medication in last 30 days or a radiopharmaceutical within seven days of imaging for this study
  • Primary or recurrent malignant disease in past five years, with the exception of resected cutaneous squamous cell carcinoma in situ, basal cell carcinoma, cervical carcinoma in situ, or in situ prostate cancer with a normal prostate-specific antigen post-treatment
  • Known history of HIV (human immunodeficiency virus)
  • Laboratory result indicating a clinically significant laboratory abnormality
  • Participation in an experimental study with an amyloid targeting therapy (e.g., immunotherapy, secretase inhibitor, selective amyloid lowering agents) unless it can be demonstrated that only placebo was received
  • Doses of chronic medications that affect the central nervous system should be stable for at least four weeks before screening
  • Benzodiazepines (depressants), sympathomimetics (stimulants), antitussive agents (cough suppressants), or potentially sedating analgesics (painkillers) cannot be taken within 24 hours of cognitive testing
  • Seizure disorder or any systemic illness affecting brain function during past five years
  • History of penetrating brain injury; serious infectious disease affecting the brain including neurosyphilis, meningitis, or encephalitis; major brain surgery
  • Meets criteria for vascular dementia
  • Enrolled in a clinical trial involving an investigational drug or device, or other type of medical/behavioral research not compatible with this study
  • Lacking adequate literacy, vision, or hearing to complete psychometric tests
  • Non-native English speaker
  • For people with Alzheimer's, must have a reliable caregiver with at least 10 hours of contact per week who can attend all site visits

If I Qualify, Who Do I Contact?

Contact study personnel listed either under the general study contact or the location nearest you.

 

Need Help?

Contact NIA’s Alzheimer’s and related Dementias Education and Referral (ADEAR) Center at 800-438-4380 or email ADEAR.

Where Is This Study Located?

South Carolina
Medical University of South Carolina
Charleston, SC 29425
Recruiting
Laura Lohnes

Source: ClinicalTrials.gov ID: N/A