NCT03269149

Brief Summary

The goal of the project is to determine the extent to which indices of inflammatory biomarkers, cognition and mood, are influenced by a partnered, dance-based intervention vs control condition in African American (AA) female family caregivers, at high risk for Alzheimer's disease (AD).

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 30, 2017

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 31, 2017

Completed
19 days until next milestone

Study Start

First participant enrolled

September 19, 2017

Completed
8.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2026

Completed
Last Updated

April 22, 2025

Status Verified

April 1, 2025

Enrollment Period

8.5 years

First QC Date

August 30, 2017

Last Update Submit

April 18, 2025

Conditions

Alzheimer's Disease

Keywords

Alzheimer's diseaseAfrican-American WomenCaregiversTangoDance-based intervention

Outcome Measures

Primary Outcomes (11)

  • Change in interleukin-7

    45 mL blood will be acquired before and after the intervention to measure the inflammatory and stress marker levels

    Before and after the intervention / control at least 20 times during 12 weeks

  • Change in interleukin-8

    45 mL blood will be acquired before and after the intervention to measure the inflammatory and stress marker levels

    Before and after the intervention / control at least 20 times during 12 weeks

  • Change in interleukin-9

    45 mL blood will be acquired before and after the intervention to measure the inflammatory and stress marker levels

    Before and after the intervention / control at least 20 times during 12 weeks

  • Change in Interleukin-10

    45 mL blood will be acquired before and after the intervention to measure the inflammatory and stress marker levels

    Before and after the intervention / control at least 20 times during 12 weeks

  • Change in interferon induced protein 10

    45 mL blood will be acquired before and after the intervention to measure the inflammatory and stress marker levels

    Before and after the intervention / control at least 20 times during 12 weeks

  • Change in macrophage derived chemokine

    45 mL blood will be acquired before and after the intervention to measure the inflammatory and stress marker levels

    Before and after the intervention / control at least 20 times during 12 weeks

  • Change in monocyte chemoattractant protein 1

    45 mL blood will be acquired before and after the intervention to measure the inflammatory and stress marker levels

    Before and after the intervention / control at least 20 times during 12 weeks

  • Change in transforming growth factor alpha

    45 mL blood will be acquired before and after the intervention to measure the inflammatory and stress marker levels

    Before and after the intervention / control at least 20 times during 12 weeks

  • Change in tumor necrosis factor alpha

    45 mL blood will be acquired before and after the intervention to measure the inflammatory and stress marker levels

    Before and after the intervention / control at least 20 times during 12 weeks

  • Change in C-reactive protein

    45 mL blood will be acquired before and after the intervention to measure the inflammatory and stress marker levels

    Before and after the intervention / control at least 20 times during 12 weeks

  • Change in serum amyloid protein

    45 mL blood will be acquired before and after the intervention to measure the inflammatory and stress marker levels

    Before and after the intervention / control at least 20 times during 12 weeks

Secondary Outcomes (17)

  • Change in Montreal Cognitive Assessment (MoCA)

    Before and after the intervention / control, offered twice per week, at least 20 times during 12 weeks

  • Change in the Tower of London test

    Before and after the intervention / control, offered twice per week, at least 20 times during 12 weeks

  • Change in the Stroop interference test

    Before and after the intervention / control, offered twice per week, at least 20 times during 12 weeks

  • Change in Trails B test

    Before and after the intervention / control, offered twice per week, at least 20 times during 12 weeks

  • Change in Digit Span test

    Before and after the intervention / control, offered twice per week, at least 20 times during 12 weeks

  • +12 more secondary outcomes

Study Arms (2)

Adapted Tango Dance

EXPERIMENTAL

20 improvisational, 90-minute adapted tango dance sessions over a 12-week period.

Other: Adapted Tango Dance

Educational Control

ACTIVE COMPARATOR

Participants will take part in at least 20 educational lectures offered twice per week over 12 weeks.

Behavioral: Educational lectures

Interventions

Adapted Tango DanceOTHER

20 improvisational, 90-minute adapted tango dance sessions over a 12-week period. Classes begin with a 20-minute standing warm-up followed by partnering and rhythmic exercises. Next, novel step elements are introduced and participants will be taught how to combine the new steps with previously learned steps via improvisation. Caregivers will dance with each other or undergraduate /graduate student volunteers. Music will be played throughout classes and artistic expression, i.e., attention to aesthetics, and improvisation, will be encouraged.

Adapted Tango Dance
Educational lecturesBEHAVIORAL

Participants will take part in at least 20 educational lectures offered twice per week over 12 weeks. Classes will also be 1.5 hours long and will involve lecture, partnered and group learning and extensive Q\&A will be encouraged.

Educational Control

Eligibility Criteria

Age45 Years - 65 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsFemales
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Women family caregivers from the Emory ADRC and Dr. Wharton's studies of Alzheimer's disease (AD) caregivers
  • Parental diagnosis 'probable AD'
  • African-American
  • years of age

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Atlanta VA Medical Center, Emory University, Executive Park, Wesley Woods

Atlanta, Georgia, 30322, United States

Location

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Study Officials

  • Madeleine Hackney

    School Of Medicine, Emory University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Asstant Professor

Study Record Dates

First Submitted

August 30, 2017

First Posted

August 31, 2017

Study Start

September 19, 2017

Primary Completion

April 1, 2026

Study Completion

April 1, 2026

Last Updated

April 22, 2025

Record last verified: 2025-04

Locations

US(1)