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

Alzheimer Disease Clinical Trial

Official title:

Neural Mechanisms of Induced Calmness After Listening to Improvisatory Music: An Investigation for Healthy Individuals and Persons With Alzheimer's Dementia

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05477862
• Other study ID #: 00215983
• Status: Enrolling by invitation
• Phase: N/A
• Start date: October 15, 2023
• Est. completion date: January 15, 2026

Study information

• Verified date: March 2024
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 30
• Est. completion date: January 15, 2026
• Est. primary completion date: October 15, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 55 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Alzheimer Disease

Intervention

Behavioral:
• Clinically Designed Improvisatory Music
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.

Locations

Country	Name	City	State
United States	Mesulam Center for Cognitive Neurology and Alzheimer's Disease	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Northwestern University

Country where clinical trial is conducted

United States, 

References & Publications (5)

Assal F, Cummings JL. Neuropsychiatric symptoms in the dementias. Curr Opin Neurol. 2002 Aug;15(4):445-50. doi: 10.1097/00019052-200208000-00007. — View Citation

Baird A, Samson S. Music and dementia. Prog Brain Res. 2015;217:207-35. doi: 10.1016/bs.pbr.2014.11.028. Epub 2015 Jan 31. — View Citation

Bonakdarpour B, McFadden A, Zlotkowski S, Huang D, Shaker M, Shibata B, Haben W, Brashear C, Sandoval A, Breitenbach C, Rodriguez C, Viamille J, Porter M, Galic K, Schaeve M, Thatcher D, Takarabe C. Neurology Telemusic Program at the Time of the COVID-19 Pandemic: Turning Hospital Time Into Aesthetic Time During Crisis. Front Neurol. 2021 Dec 13;12:749782. doi: 10.3389/fneur.2021.749782. eCollection 2021. — View Citation

Lyketsos CG, Carrillo MC, Ryan JM, Khachaturian AS, Trzepacz P, Amatniek J, Cedarbaum J, Brashear R, Miller DS. Neuropsychiatric symptoms in Alzheimer's disease. Alzheimers Dement. 2011 Sep;7(5):532-9. doi: 10.1016/j.jalz.2011.05.2410. — View Citation

Seeley WW, Menon V, Schatzberg AF, Keller J, Glover GH, Kenna H, Reiss AL, Greicius MD. Dissociable intrinsic connectivity networks for salience processing and executive control. J Neurosci. 2007 Feb 28;27(9):2349-56. doi: 10.1523/JNEUROSCI.5587-06.2007. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Neuropsychiatric Inventory (NPI) [NPI-1: pre-intervention; NPI-2: post-intervention]	Change in NPI (NPI-2 minus NPI-1)	Through study completion (3 years)
Primary	Change in Beck Anxiety Inventory [BAI-1: pre-intervention; BAI-2: post-intervention]	Change in BAI (BAI-2 minus BAI-1)	Through study completion (3 years)
Secondary	Change in Systolic Blood Pressure [SBP-1: pre-intervention; SBP-2: post-intervention]	Change in SBP (SBP-2 minus SBP-1)	Through study completion (3 years)
Secondary	Change in Heart rate [HR-1: pre-intervention; HR-2: post-intervention]	Change in HR (HR-2 minus HR-1)	Through study completion (3 years)
Secondary	Change Respiratory Rate [RR-1: pre-intervention; RR-2: post-intervention]	Change in RR (RR-2 minus RR-1)	Through study completion (3 years)
Secondary	Change in Skin conductance [SC-1: pre-intervention; SC-2: post-intervention]	Change in SC (SC-2 minus SC-1)	Through study completion (3 years)
Secondary	Change in Resting state functional connectivity MRI	Functional Connectivity within three resting state networks: Change in Default Network (DN), Change in Salience Network (SN), and Change in Reward Network (RN).	Through study completion (3 years)