Hearing intervention (HI) group for Dementia

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Wake Forest University, Winston-Salem, NC
Dementia+5 More
Successful aging/delayed hearing intervention - Other
Eligibility
65+
All Sexes
What conditions do you have?
Select

Study Summary

The ACHIEVE Brain Health Follow-Up Study is a 3-year follow-up to the Aging and Cognitive Health Evaluation in Elders (ACHIEVE) randomized study to determine the long-term effect of hearing intervention vs. successful aging/delayed hearing intervention on rates of cognitive decline and incident mild cognitive impairment or dementia.

Eligible Conditions

  • Mild Cognitive Impairment (MCI)
  • Dementia
  • Hearing Loss
  • Aging
  • Cognitive Decline

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Study Objectives

2 Primary · 5 Secondary · Reporting Duration: If in ACHIEVE-MRI: ACHIEVE Baseline, ACHIEVE-BHFU Year 3 (~6 years); if not in ACHIEVE-MRI: ACHIEVE-BHFU Baseline, ACHIEVE-BHFU Year 3 (~2.5 years)

6 years
Mild cognitive impairment (MCI) / dementia
Year 6
Change in cognition executive function domain
Change in cognition language domain
Change in cognition memory domain
Change in global cognition
Year 6
Change in regional brain volumes
Change in white matter tract integrity

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Trial Design

2 Treatment Groups

Hearing intervention (HI) group
1 of 2
Successful aging/Delayed hearing intervention (SA/DHI) group
1 of 2
Active Control

859 Total Participants · 2 Treatment Groups

Primary Treatment: Hearing intervention (HI) group · No Placebo Group · Phase 3

Hearing intervention (HI) group
Other
ActiveComparator Group · 1 Intervention: Hearing intervention · Intervention Types: Other
Successful aging/Delayed hearing intervention (SA/DHI) group
Other
ActiveComparator Group · 1 Intervention: Successful aging/delayed hearing intervention · Intervention Types: Other

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: if in achieve-mri: achieve baseline, achieve-bhfu year 3 (~6 years); if not in achieve-mri: achieve-bhfu baseline, achieve-bhfu year 3 (~2.5 years)
Closest Location: Wake Forest University · Winston-Salem, NC
2004First Recorded Clinical Trial
2 TrialsResearching Dementia
124 CompletedClinical Trials

Eligibility Criteria

Age 65+ · All Participants · 9 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are eligible for the ACHIEVE trial.
You have a speech recognition score in quiet of 60% or more in the better ear.
You have a high school degree or less.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.