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Search / Trial NCT05477862

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

Launched by NORTHWESTERN UNIVERSITY · Jul 26, 2022

Trial Information

Current as of November 02, 2025

Enrolling by invitation

Keywords

Anxiety Alzheimer Dementia Agitation Irritability Music Intervention Music Medicine Music Improvisation

ClinConnect Summary

This study is exploring whether Clinically Designed Improvisatory Music (CDIM)—live, improvised music intended to promote calm—can help reduce anxiety and calmness-related symptoms in two groups: 15 adults with Alzheimer’s disease and 15 cognitively healthy adults. There is no drug or device involved. Participants will undergo music sessions and be assessed for anxiety and other responses. Scientists will measure changes in anxiety scores, neuropsychiatric symptoms, and also track vital signs (like blood pressure, heart rate, breathing, and skin conductance) as well as brain activity and connectivity using MRI.

Eligibility is centered on age and cognitive status. Adults are 55 to 85 years old. The Alzheimer’s group can participate if they have mild to moderate dementia (MMSE above 15 and Clinical Dementia Rating 0.5 to 2) and a history or current signs of agitation or anxiety (Beck Anxiety Inventory score over 8). The cognitively healthy group must have anxiety symptoms (BAI over 8) but no dementia. Hearing must be adequate to participate. The study is taking place at Northwestern University’s Mesulam Center in Chicago, and enrollment is by invitation. It is a non-randomized, open-label design (two parallel groups both receiving the music intervention), with study completion expected in 2026. This is an early, exploratory look at how music might help with anxiety and what happens in the brain, not a proven treatment.

Gender

ALL

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

About Northwestern University

Northwestern University is a prestigious academic institution renowned for its commitment to advancing medical research and improving patient care through innovative clinical trials. With a robust infrastructure that supports interdisciplinary collaboration, Northwestern leverages its expertise in various fields, including medicine, engineering, and social sciences, to drive groundbreaking studies. The university is dedicated to adhering to the highest ethical standards and regulatory compliance, ensuring that all clinical trials are conducted with the utmost integrity and focus on participant safety. Through its Clinical Trials Office, Northwestern aims to translate scientific discoveries into effective therapies, ultimately enhancing health outcomes and contributing to the broader medical community.

Locations

Chicago, Illinois, United States

Patients applied

0 patients applied

Trial Officials

Borna Bonakdarpour, MD, FAAN

Principal Investigator

Northwestern Mesulam Center for Cognitive Neurology and Alzheimer Disease

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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