RECRUITING

Partnered Rhythmic Rehabilitation in Prodromal Alzheimer's Disease

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Partnered Rhythmic Rehabilitation for Enhanced Motor-Cognition in Prodromal Alzheimer's Disease

Quick Facts

Study Start:2019-10-29

Study Completion:2025-04

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04029623

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:50 Years to 80 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* 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	* 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

Inclusion Criteria

Exclusion Criteria

* 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

* 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

Contacts and Locations

Study Contact

Madeleine Hackney, PhD

CONTACT

404-321-6111

mehackn@emory.edu

Principal Investigator

Madeleine Hackney, PhD

PRINCIPAL_INVESTIGATOR

Emory University

Study Locations (Sites)

Emory University

Atlanta, Georgia, 30322

United States

Collaborators and Investigators

Sponsor: Emory University

Madeleine Hackney, PhD, PRINCIPAL_INVESTIGATOR, Emory University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2019-10-29

Study Completion Date2025-04

Study Record Updates

Study Start Date2019-10-29

Study Completion Date2025-04

Terms related to this study

Additional Relevant MeSH Terms

Prodromal Alzheimer's Disease