Alzheimer Disease Clinical Trial
Official title:
Music Therapy for Autobiographical Memory and Neuropsychiatric Symptoms in Alzheimer Disease
NCT number | NCT05151562 |
Other study ID # | IRB00274248 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | July 18, 2022 |
Est. completion date | April 2026 |
This study is designed to assess the feasibility that individualized reminiscence-based virtual music therapy sessions can enhance autobiographical memory, mood, and cognition in patients with mild cognitive impairment (MCI) or mild dementia due to Alzheimer's Disease (AD). 60 patients with MCI or mild dementia due to AD will receive two 30 minutes reminiscence-targeted virtual music therapy interventions per week for 8 weeks (a total of 16 sessions). Participants' (or supported by the study partner) self-reported and measurable outcomes including cognitive, anxiety, quality of life, and autobiographical memory will be assessed before and after the 8-week course of treatment. Blood-oxygenation level-dependent (BOLD) in functional magnetic resonance imaging (fMRI) will also be also measured before and after the 8-week course of treatment.
Status | Recruiting |
Enrollment | 60 |
Est. completion date | April 2026 |
Est. primary completion date | April 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 89 Years |
Eligibility | Inclusion Criteria: - Age 18-89 - Mild Cognitive Impairment (MoCA score: 18-25) or Early AD (MoCA score: 17-24) Exclusion Criteria: - Head trauma, traumatic brain injury, or concussion with loss of consciousness for >2 minutes - Claustrophobia incompatible with MRI scanning - Medical device incompatible with MRI scanning (e.g. cardiac pacemaker, implanted cardiac defibrillator, aneurysm brain clip, inner ear implant) - Prior history as a metal worker and/or certain metallic objects in the body - Exclusion Criteria will be carefully determined by the MRI screening form. |
Country | Name | City | State |
---|---|---|---|
United States | Johns Hopkins School of Medicine | Baltimore | Maryland |
Lead Sponsor | Collaborator |
---|---|
Johns Hopkins University |
United States,
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Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in autobiographical memory level as assessed by Autobiographical Memory Test (AMT) | AMT is used to assess the degree of specificity of autobiographical memory. The AMT usually contains cue words of both positive and negative valence, but it is unclear whether these valences form separate factors or not. Participants are asked to generate a specific memory that happened on a particular day at least one week ago. The number of specific memories recalled on each AMT is used as the dependent variable, and a higher frequency indicates a greater autobiographical memory level. Scores are on a scale from 1 to 7, where higher scores indicate greater familiarity/imageability. | Baseline and Post-test Week 12 | |
Primary | Change in scores on neuropsychiatric symptom level as assessed by Neuropsychiatric Inventory Questionnaire (NPI-Q) (caregivers) | The NPI-Q is designed to be a self-administered questionnaire completed by informants about patients for whom they care. Each of the 12 NPI-Q domains contains a survey question that reflects cardinal symptoms of that domain. The severity scale has scores ranging from 1 to 3 points (1=mild; 2=moderate; and 3=severe; total score range: 0 - 36) and the scale for assessing caregiver distress has scores ranging from 0 to 5 points (0=no distress; 1=minimal distress; 2=mild distress; 3=moderate distress; 4=severe distress; and 5=extreme distress; total score range: 0-60). | Baseline and Post-test Week 12 | |
Secondary | Change in cortical activation as assessed by Blood Oxygen Level Dependent (BOLD) on functional magnetic resonance imaging (fMRI) | Blood Oxygen Level dependent (BOLD) signal (in percentage), detected on fMRI, reflects change in deoxyhemoglobin driven by localized changes in brain blood flow and blood oxygenation during music listening. The percentage of change from baseline will be used. | Baseline and Post-test Week 12 | |
Secondary | Change in cognition as assessed by the Montreal Cognitive Assessment (MoCA) | Montreal Cognitive Assessment (MoCA) is a rapid cognitive screening test that assesses cognitive performance in multiple domains including visuo-spatial and executive functions, naming, memory, attention, language, abstraction, and orientation. Scores on the MoCA range from 0 to 30:
> 26 = normal 18-25 = mild cognitive impairment 10-17 = moderate cognitive impairment < 10 = severe cognitive impairment |
Baseline and Post-test Week 12 | |
Secondary | Change in quality of life as assessed by the Quality of Life for Alzheimer's Disease (QoL-AD) | The QOL-AD is administered in interview format to individuals with dementia. It is a 13-item questionnaire designed to provide both a patient and a caregiver report of the quality of life (QOL). Points are assigned to each item as follows: poor = 1, fair = 2, good = 3, excellent = 4. The total score is the sum of all 13 items. | Baseline and Post-test Week 12 | |
Secondary | Change in nostalgia level as assessed by Southampton Nostalgia Scale (SNS) | SNS is a psychometric instrument that measures human's nostalgia proneness consisting of seven questions that assess a person's attitude towards nostalgia, the degree of experience or tendency to nostalgic feelings and the nostalgia frequency. The score range for each item is from 1 (not at all) to 7 (very much). | Baseline and Post-test Week 12 | |
Secondary | Change in anxiety level as assessed by State-Trait Anxiety Inventory (STAI) | The Spielberger State-Trait Anxiety Inventory (STAI) is a 40-item self-report measure of anxiety using a 4-point Likert-type scale (from 0 to 3 points) for each item. The total score ranges from 0-63. The following guidelines are recommended for the interpretation of scores: 0-9, normal or no anxiety; 10-18, mild to moderate anxiety; 19-29, moderate to severe anxiety; and 30-63, severe anxiety. | Baseline and Post-test Week 12 | |
Secondary | Change in depression level as assessed by Geriatric Depression Scale (GDS) | The 15-item geriatric depression scale (GDS-15) is a short form of GDS and is used to screen, diagnose, and evaluate depression in elderly individuals. Most previous studies evaluated the ability of GDS-15 to discriminate between depressive and non-depressive states. Of the 15 items, 10 indicated the presence of depression when answered positively, while the rest (question numbers 1, 5, 7, 11, 13) indicated depression when answered negatively. Scores of 0-4 are considered normal, depending on age, education, and complaints; 5-8 indicate mild depression; 9-11 indicate moderate depression; and 12-15 indicate severe depression. | Baseline and Post-test Week 12 | |
Secondary | Change in score/statement on music therapy experiences as assessed by the structured interview reporting form | The participants will be given a brief reporting form after each virtual music therapy session to generate descriptive data about interventions used most frequently and connected theory (e.g. why participants chose specific interventions during the sessions). | Day 1, Day 3, Day 8, Day 10, Day 15, Day 17, Day 22, Day 24, Day 29, Day 31, Day 36, Day 38, Day 43, Day 45, Day 50, Day 52 |
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