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

Not Applicable

• Conditions: Alzheimer Disease
• Interventions: Behavioral: Clinically Designed Improvisatory Music

• Registration Number: NCT05477862
• Lead Sponsor: Northwestern University

Brief Summary

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).

Detailed 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.

Study Timeline

• Study First Submitted: 2022-07-17
• Study First Submitted QC: 2022-07-26
• Study First Posted: 2022-07-28
• Study Start: 2023-10-15
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-20
• Last Update Posted: 2024-03-22
• Primary Completion: 2025-10-15
• Study Completion: 2026-01-15

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Alzheimer Disease (AD)	Clinically Designed Improvisatory Music	-
Cognitively Healthy (CH)	Clinically Designed Improvisatory Music	-

Primary Outcome Measures

Name	Time	Method
Change in Neuropsychiatric Inventory (NPI) [NPI-1: pre-intervention; NPI-2: post-intervention]	Through study completion (3 years)	Change in NPI (NPI-2 minus NPI-1)
Change in Beck Anxiety Inventory [BAI-1: pre-intervention; BAI-2: post-intervention]	Through study completion (3 years)	Change in BAI (BAI-2 minus BAI-1)

Secondary Outcome Measures

Name	Time	Method
Change in Skin conductance [SC-1: pre-intervention; SC-2: post-intervention]	Through study completion (3 years)	Change in SC (SC-2 minus SC-1)
Change in Heart rate [HR-1: pre-intervention; HR-2: post-intervention]	Through study completion (3 years)	Change in HR (HR-2 minus HR-1)
Change in Resting state functional connectivity MRI	Through study completion (3 years)	Functional Connectivity within three resting state networks: Change in Default Network (DN), Change in Salience Network (SN), and Change in Reward Network (RN).
Change in Systolic Blood Pressure [SBP-1: pre-intervention; SBP-2: post-intervention]	Through study completion (3 years)	Change in SBP (SBP-2 minus SBP-1)
Change Respiratory Rate [RR-1: pre-intervention; RR-2: post-intervention]	Through study completion (3 years)	Change in RR (RR-2 minus RR-1)

Trial Locations

Locations (1)

Mesulam Center for Cognitive Neurology and Alzheimer's Disease; 🇺🇸 Chicago, Illinois, United States