Partnered Rhythmic Rehabilitation in Prodromal Alzheimer's Disease

Completed · Not applicable

Conditions studied: Prodromal Alzheimer's Disease

In brief

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). Functional decline in AD is severely impacted by impaired ability to do physical actions while having to make decisions and concentrating, something scientists call motor-cognitive integration. Combined motor and cognitive training has been recommended for people with early AD, thus this study will use partnered, rhythmic rehabilitation (PRR), as an intervention to simultaneously target cardiovascular, social and motor-cognitive domains important to AD. PRR is moderate intensity, cognitively-engaging social dance that targets postural control systems, involves learning multiple, varied stepping and rhythmic patterns, and fosters tactile communication of motor goals between partners, enhancing social interaction's effect on cognition. Previous research demonstrates that PRR classes are safe and result in no injurious falls. This study is a 12-month long Phase II single- blind randomized clinical trial using PRR in 66 patients with early AD. Participants with early AD will be randomly assigned to participate in PRR or a walking program for three months of biweekly sessions, followed by nine months of weekly sessions of PRR or walking. The overarching hypothesis is that PRR is safe, tolerable and associated with improved motor-cognitive function, and brain (neuronal), vascular (blood vessels) and inflammatory biomarkers that might affect function.

Key facts

Study ID: NCT04029623
Run by: Emory University
People needed: 76
Starts: 2019-10-29
Expected to finish: 2025-09-16
Last updated by the study team: 2026-05-26

Who can join

Age: 50 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

Emory University — Atlanta, Georgia, United States

Full record on ClinicalTrials.gov

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