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

NCT05477862 | Enrolling By Invitation DMC

• 1 other identifier: 00215983
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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).

Conditions

Alzheimer Disease

Keywords

Anxiety; Alzheimer; Dementia; Agitation; Irritability; Music Intervention; Music Medicine; Music Improvisation

Outcome Measures

Primary Outcomes (2)

• 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)

• 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 Outcomes (5)

• Change in Systolic Blood Pressure [SBP-1: pre-intervention; SBP-2: post-intervention]

  Through study completion (3 years)

• Change in Heart rate [HR-1: pre-intervention; HR-2: post-intervention]

  Through study completion (3 years)

• Change Respiratory Rate [RR-1: pre-intervention; RR-2: post-intervention]

  Through study completion (3 years)

• Change in Skin conductance [SC-1: pre-intervention; SC-2: post-intervention]

  Through study completion (3 years)

• Change in Resting state functional connectivity MRI

  Through study completion (3 years)

Study Arms (2)

Alzheimer Disease (AD)

EXPERIMENTAL

Behavioral: Clinically Designed Improvisatory Music

Cognitively Healthy (CH)

EXPERIMENTAL

Behavioral: Clinically Designed Improvisatory Music

Interventions

Clinically Designed Improvisatory Music BEHAVIORAL

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.

Alzheimer Disease (AD); Cognitively Healthy (CH)

Eligibility Criteria

• Age: 55 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Northwestern University: lead

Study Sites (1)

Mesulam Center for Cognitive Neurology and Alzheimer's Disease

Chicago, Illinois, 60611, United States

Location

Related Publications (5)

• 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.

  PMID: 34966344 BACKGROUND

• 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.

  PMID: 21889116 BACKGROUND

• 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.

  PMID: 25725917 BACKGROUND

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

  PMID: 12151841 BACKGROUND

• 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.

  PMID: 17329432 BACKGROUND

MeSH Terms

Conditions

Alzheimer Disease; Anxiety Disorders; Dementia; Psychomotor Agitation

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Dyskinesias; Neurologic Manifestations; Psychomotor Disorders; Neurobehavioral Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Aberrant Motor Behavior in Dementia; Behavioral Symptoms; Behavior

Study Officials

• Borna Bonakdarpour, MD, FAAN

  Northwestern Mesulam Center for Cognitive Neurology and Alzheimer Disease

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Neurology

Model Details: 15 individuals with Alzheimer Disease (AD) and 15 cognitively healthy individuals.

Study Record Dates

• First Submitted: July 17, 2022
• First Posted: July 28, 2022
• Study Start: October 15, 2023
• Primary Completion: October 15, 2025
• Study Completion: January 15, 2026
• Last Updated: March 22, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)