Actively Recruiting

Phase Not Applicable
Age: 50Years - 80Years
All Genders
NCT04029623

Partnered Rhythmic Rehabilitation in Prodromal Alzheimer's Disease

Led by Emory University · Updated on 2025-04-23

66

Participants Needed

1

Research Sites

348 weeks

Total Duration

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Sponsors

E

Emory University

Lead Sponsor

N

National Institute on Aging (NIA)

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Partnered Rhythmic Rehabilitation in Prodromal Alzheimer's Disease

Who Can Participate

Age: 50Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosis of amnestic mild cognitive impairment according to AD Neuroimaging Initiative criteria
  • Subjective memory concern or memory problem noted by a partner
  • Abnormal memory function based on standardized memory tests
  • Mini-Mental State Exam score between 24 and 30 (inclusive)
  • Clinical Dementia Rating of 0.5 with memory box score at least 0.5
  • Preserved general functional performance
  • Ability to walk 10 or more feet without assistive device
  • Completed at least six grades of education or has a good work history
  • Engages in less than 150 minutes of moderate or 75 minutes of vigorous aerobic activity per week
  • Not involved in any structured exercise program in past 3 months
  • No hospitalization in the last 60 days
  • Willing to commit to a one-year research program
Not Eligible

You will not qualify if you...

  • Acute medical illness requiring hospitalization
  • Uncontrolled congestive heart failure
  • History of stroke within past three years
  • Inability to perform study procedures
  • Inability to undergo MRI (e.g., metal implants, pacemaker, claustrophobia)
  • Medical or physical conditions preventing participation (e.g., severe arthritis, uncontrolled hypertension or diabetes, renal failure, angina with activity)
  • Use of medications adversely affecting cognition (e.g., antipsychotics, opioids, stimulants, chemotherapy, anti-Parkinsonian drugs)
  • Not on stable doses of Aricept or anticholinesterase inhibitors for at least 3 months
  • Psychotic disorders
  • Confounding neurological conditions (e.g., CNS infections, seizures, head injury with prolonged unconsciousness, brain tumors, stroke with sequelae)
  • Substance use disorder, major depressive or generalized anxiety disorder within six months of evaluation

AI-Screening

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Trial Site Locations

Total: 1 location

1

Emory University

Atlanta, Georgia, United States, 30322

Actively Recruiting

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Research Team

M

Madeleine Hackney, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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