Alzheimer Disease Clinical Trial
Official title:
Racial Variation in Response to Music Interventions for People With Alzheimer's Dementia
NCT number | NCT04282798 |
Other study ID # | IRB00231227 |
Secondary ID | |
Status | Withdrawn |
Phase | N/A |
First received | |
Last updated | |
Start date | June 2020 |
Est. completion date | March 2021 |
Verified date | June 2020 |
Source | Johns Hopkins University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This project will study the efficacy of a personalized receptive music intervention on neuropsychiatric symptoms and general cognitive function in patients with mild and moderate Alzheimer's disease (AD) by race.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | March 2021 |
Est. primary completion date | March 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility |
Inclusion Criteria: - Diagnosis of Alzheimer's disease - English speaking Exclusion Criteria: - Deaf or hard of hearing |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Johns Hopkins University |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in severity of neuropsychiatric symptoms as assessed by the Neuropsychiatric Inventory-Questionnaire (NPI-Q) severity score | Examining changes in the NPI-Q which is an informant-based interview that assesses 12 neuropsychiatric symptoms of the participant. The NPI-Q includes 12 neuropsychiatric domains. Initial responses to each domain question are "Yes" (present) or "No" (absent). If the response to the domain question is "No", the informant goes to the next question. If "Yes", the informant then rates the severity of the symptoms present on a 3-point scale where 1 is "mild" and 3 is "severe". | Initial and final visit, four weeks apart | |
Primary | Change in Montreal Cognitive Assessment (MoCA) score | Examining changes in the MoCA which is a cognitive test for Alzheimer's disease. The MoCA assesses different cognitive domains: attention and concentration, executive functions, memory, language, visuoconstructional skills, conceptual thinking, calculations, and orientation to time and place. MoCA total scores range between 0 and 30; 18-25 = mild cognitive impairment, 10-17 = moderate cognitive impairment and less than 10 = severe cognitive impairment. | Initial and final visit, four weeks apart | |
Secondary | Correlation between the Barcelona Music Reward Questionnaire (BMRQ) score and NPI-Q score | The 20-item Barcelona Music Reward Questionnaire (administered at enrollment) assesses facets of the music and reward experiences with 5 factors: Musical Seeking, Emotion Evocation, Mood Regulation, Social Reward, and Sensory-Motor. Participants indicate the level of agreement with each statement by using a five-point scale ranging from ''fully disagree'' (1) to ''fully agree'' (5). BMRQ total scores range between 20 and 100. BMRQ total scores and NPI-Q totals scores will be used to assess whether these variables correlate. The correlation will be completed via statistical analysis in a chi squared test. | At the end of the study, up to 9 months | |
Secondary | Correlation between the BMRQ score and MoCA score | The 20-item BMRQ (administered at enrollment) assesses facets of the music and reward experiences with 5 factors: Musical Seeking, Emotion Evocation, Mood Regulation, Social Reward, and Sensory-Motor. Participants indicate the level of agreement with each statement by using a five-point scale ranging from ''fully disagree'' (1) to ''fully agree'' (5). BMRQ total scores range between 20 and 100. BMRQ total scores and MoCA total scores will be used to assess whether these variables correlate. The correlation will be completed via statistical analysis in a chi squared test. | At the end of the study, up to 9 months |
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