Recruiting

CDIM

Sponsor:

Northwestern University

Code:

NCT07775625

Conditions

Alzheimer's Disease

Eligibility Criteria

Sex: All

Age: 55+

Healthy Volunteers: Not accepted

Interventions

Clinically Designed Improvisatory Music

Listening to Storytelling

Study Details

Brief summary:

This study examines whether Clinically Designed Improvisatory Music (CDIM) can reduce anxiety in people living with Alzheimer's disease and anxiety (AD-A), and whether it can also lessen caregiver burden. CDIM is a live, receptive music-based intervention that uses slow tempi, simple diatonic melodic lines, soft dynamics, and periodic pauses to promote relaxation. As described in the proposal, CDIM has previously been shown to reduce stress and improve physiological markers such as heart rate, blood pressure, and EEG alpha/beta ratios (CDIM significantly decreased physical stress symptoms and patients also reported positive emotional outcomes and EEG readings showed increased alpha/beta brainwave ratios ).

The study will enroll 30 dyads (individuals with AD-A and their caregivers). Dyads will be randomly assigned to either CDIM or a control intervention (CI) consisting of calming short stories read aloud. Both interventions include eight 30-minute sessions over four weeks, delivered in alternating in-person and virtual formats.

The primary goal is to determine whether CDIM is feasible and effective in reducing anxiety in individuals with AD-A, measured by the Rating Anxiety in Dementia (RAID) scale, and in reducing caregiver burden, measured by the Zarit Burden Interview (ZBI). The study also evaluates changes in heart rate and blood pressure as indicators of autonomic regulation.

A second goal is to explore whether CDIM improves central auditory processing, assessed using the frequency-following response (FFR). The proposal notes that central auditory processing declines with age and dementia and may contribute to anxiety. FFR will be measured before and after the intervention to determine whether CDIM enhances neural timing and response magnitude.

Overall, this pilot study aims to determine whether CDIM is a feasible, safe, and potentially effective non-pharmacological intervention for reducing anxiety in individuals with AD-A and decreasing caregiver burden, while also investigating its underlying neurophysiological mechanisms.

Conditions

Alzheimer's Disease

Study ID

NCT07775625

Start date

Feb 2, 2026

Status verified date

Aug, 2026

Completion date

Dec 15, 2026

Anticipated

Primary completion date

Dec 15, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 55+

Healthy Volunteers: Not accepted

Inclusion Criteria

  • Clinical diagnosis of Alzheimer's Disease
  • Positive Alzheimer's disease biomarkers (blood test, amyloid PET scan or CSF)
  • Mini-mental State Exam (MMSE) >=15
  • Rating for Anxiety in Dementia (RAID) score > 8

Exclusion Criteria

  • Significant hearing impairments
  • Major comorbidities Beck Depression Inventory (BDI) scores above > 10'

Study Design

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Clinically Designed Improvisatory Music

active comparator: Listening to storytelling

Interventions

Clinically Designed Improvisatory Music

Clinically Designed Improvisatory Music (CDIM) is live, slow-tempo, diatonic improvisation played with soft dynamics and periodic pauses. It uses meterless melodic lines, vocal-range pitches, and gentle harmonic intervals to promote neural entrainment, parasympathetic activation, and anxiety reduction in listeners.

Listening to Storytelling

Participants will listen to calming short stories within 30 minutes.

Primary outcome measure

  • Rating Anxiety in Dementia (RAID) [ Time Frame: From enrollment to the end of treatment at 8 weeks. ]

Central Contacts and Locations

Central contacts

Borna Bonakdarpour - Associate Professor, MD, FAAN, FANA

(312) 503-5170bbk@northwestern.edu

Locations

Northwestern University Feinberg School of Medicine

Recruiting

Chicago, Illinois, United States, 60611

More Information

Sponsor

Northwestern University

Last update posted

Aug 20, 2026

Last verified

Aug, 2026

Keywords

  • Music-based intervention
  • Anxiety
  • Alzheimer's disease

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Northwestern University on 2026-08-20.