Clinical trial NCT05477862: Neural Mechanisms of Clinically Designed Improvisatory Music for Alzheimer's Disease
Official title: Neural Mechanisms of Induced Calmness After Listening to Improvisatory Music: An Investigation for Healthy Individuals and Persons With Alzheimer's Dementia
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Alzheimer Disease
Keywords: Anxiety
Alzheimer
Dementia
Agitation
Irritability
Music Intervention
Music Medicine
Music Improvisation
Lead sponsor: Northwestern University
Sponsor class: OTHER
First posted: 2022-07-28
Enrollment: 30
Sex: ALL
Minimum age (years): 55
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 15 individuals with Alzheimer Disease (AD) and 15 cognitively healthy individuals.
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility 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

Primary outcomes:
measure: Change in Neuropsychiatric Inventory (NPI) [NPI-1: pre-intervention; NPI-2: post-intervention]
timeFrame: Through study completion (3 years)
measure: Change in Beck Anxiety Inventory [BAI-1: pre-intervention; BAI-2: post-intervention]
timeFrame: Through study completion (3 years)
Secondary outcomes:
measure: Change in Systolic Blood Pressure [SBP-1: pre-intervention; SBP-2: post-intervention]
timeFrame: Through study completion (3 years)
measure: Change in Heart rate [HR-1: pre-intervention; HR-2: post-intervention]
timeFrame: Through study completion (3 years)
measure: Change Respiratory Rate [RR-1: pre-intervention; RR-2: post-intervention]
timeFrame: Through study completion (3 years)
measure: Change in Skin conductance [SC-1: pre-intervention; SC-2: post-intervention]
timeFrame: Through study completion (3 years)
measure: Change in Resting state functional connectivity MRI
timeFrame: Through study completion (3 years)
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Mesulam Center for Cognitive Neurology and Alzheimer's Disease
state: Illinois
Study officials:
affiliation: Northwestern Mesulam Center for Cognitive Neurology and Alzheimer Disease
name: Borna Bonakdarpour, MD, FAAN
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
citation: Assal F, Cummings JL. Neuropsychiatric symptoms in the dementias. Curr Opin Neurol. 2002 Aug;15(4):445-50. doi: 10.1097/00019052-200208000-00007.
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.