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Neural Mechanisms of Clinically Designed Improvisatory Music for Alzheimer's Disease

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Northwestern University

Status

Invitation-only

Conditions

Alzheimer Disease

Treatments

Behavioral: Clinically Designed Improvisatory Music

Study type

Interventional

Funder types

Other

Identifiers

NCT05477862
00215983

Details and patient eligibility

About

Clinically Designed Improvisatory Music (CDIM) is a form of improvised music based on calm-inducing sound parameters which brought relief to our cohort of neurology patients. As a direct sound-based approach, CDIM does not rely on autobiographical memory and may have wider applicability and generalizability. We wish to examine if CDIM decreases anxiety in 15 cognitively healthy individuals and 15 Alzheimer Disease patients with anxiety (AD-A).

Full description

The goal of this study is to identify the neural mechanisms of induced calmness through live clinically designed improvisatory music (CDIM) in cognitively healthy individuals and persons with Alzheimer's dementia suffering from agitation. This study is novel as most music interventions for dementia use familiar music and the underlying neural mechanism of calmness induced by music is not well known. We plan to investigate changes in 3 major large-scale brain networks using functional magnetic resonance imaging (fMRI). The major questions we plan to answer are as follows: 1. How does improvisatory music change the connectivity within brain emotion related networks in neurotypical individuals? 2. Does improvisatory music induce a state of calmness in individuals with Alzheimer's dementia and how? Based on objective evidence provided by this study we can justify further usage of music for patients with Alzheimer's, in particular, in the form of improvisation.

Enrollment

30 estimated patients

Sex

All

Ages

55 to 85 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

  1. Cognitively healthy individuals

    Cognitively healthy control participants evaluated through the Northwestern Mesulam Center. BAI > 8.

    Exclusion Criteria: hearing loss

  2. Individuals with mild to moderate Alzheimer's disease

This group will similarly be recruited through the Mesulam Center. All individuals recruited by the research Core at the center are well characterized tests standardized across all NIH funded Alzheimer Centers across the nation. Individuals with mild to moderate neurocognitive disorder due to AD will have an MMSE greater than >15 and Clinical Dementia Rating (CDR) between 0.5 and 2.. They will also have a history of neurocognitive-related agitation/anxiety, and a Beck Anxiety Index (BAI) greater than 8, suggestive of at least a mild level of anxiety.

Exclusion criteria: MMSE<15, CDR>2, hearing loss

Trial design

Primary purpose

Supportive Care

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

30 participants in 2 patient groups

Alzheimer Disease (AD)
Experimental group
Treatment:
Behavioral: Clinically Designed Improvisatory Music
Cognitively Healthy (CH)
Experimental group
Treatment:
Behavioral: Clinically Designed Improvisatory Music

Trial contacts and locations

1

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Central trial contact

Clara Takarabe, BA, CMP; Borna Bonakdarpour, MD, FAAN

Data sourced from clinicaltrials.gov

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