Status:
RECRUITING
Partnered Rhythmic Rehabilitation in Prodromal Alzheimer's Disease
Lead Sponsor:
Emory University
Collaborating Sponsors:
National Institute on Aging (NIA)
Conditions:
Prodromal Alzheimer's Disease
Eligibility:
All Genders
50-80 years
Phase:
NA
Brief Summary
Interventions that affect many different aspects of human ability rather than just one aspect of human health are more likely to be successful in preventing and treating Alzheimer's disease (AD). Func...
Detailed Description
For people with early Alzheimer's disease (AD), treatment options to prevent declined function are extremely limited, because AD affects many areas of function. In early AD, people may have trouble ph...
Eligibility Criteria
Inclusion
- Amnestic mild cognitive impairment (MCI) will be defined using the AD Neuroimaging Initiative (ADNI) criteria (http://www.adni-info.org/Scientists/ADNIStudyProcedures.aspx). All MCI participants in ADNI are required to have an amnestic subtype defined as:
- Subjective memory concern or a memory problem noted by their partner
- Abnormal memory function documented by a specified education adjusted cutoff score on the delayed paragraph recall of the Anna Thompson story of the Logical Memory subtest from the Wechsler Memory Scale-Revised
- Mini-Mental State Exam (MMSE) score between 24 and 30 (inclusive). Exceptions may be made for subjects with less than 8 years of education at the discretion of the PI
- Single or multi-domain amnestic MCI (both subtypes are at high risk for progression to AD)
- Clinical Dementia Rating (CDR) = 0.5 (Memory Box score must be at least 0.5)
- General functional performance sufficiently preserved
- Ability to walk 10 or more feet without an assistive device
- Completed six grades of education or has a good work history (sufficient to exclude intellectual disabilities)
- Achieves less than 150 minutes of moderate intensity or 75 minutes of vigorous intensity aerobic activity per week, which is the recommended amount of weekly exercise as per the US Department of Health and Human Services. Not involved in any structured exercise program within the past 3 months (brisk walks are considered formal exercise but leisurely walks are not)
- Not hospitalized within the last 60 days
- Willing to commit to a one year research program
Exclusion
- Acute medical illness requiring hospitalization
- Uncontrolled congestive heart failure
- History of stroke in the past three years
- Inability to perform study procedures
- Inability to perform MRI (e.g. metal implants or cardiac pacemaker, claustrophobia)
- Medical or physical conditions that would preclude participation (e.g., severe arthritis or mobility problems, uncontrolled hypertension or diabetes, renal failure, history of angina with activity)
- On medications that could adversely affect cognition, eg: antipsychotics, opioids, stimulants, chemotherapy, anti-parkinsonian drugs (eg Levodopa), neurologic prescriptions to treat Multiple sclerosis and/or Parkinson's. Patients will also be excluded if they are not on stable doses of Aricept, or anticholinesterase inhibitors, eg Namenda, for at least 3 months
- Psychotic disorders
- Confounding neurologic conditions (e.g., active central nervous system (CNS) opportunistic infections, seizure disorders, head injury with loss of consciousness \>30 minutes, intracranial neoplasms, stroke with neurological or neuropsychiatric sequelae)
- Substance Use Disorder, Major Depressive and Generalized Anxiety Disorders within six months of evaluation
Key Trial Info
Start Date :
October 29 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2026
Estimated Enrollment :
66 Patients enrolled
Trial Details
Trial ID
NCT04029623
Start Date
October 29 2019
End Date
July 1 2026
Last Update
April 23 2025
Active Locations (1)
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1
Emory University
Atlanta, Georgia, United States, 30322