ClinicalTrials.gg
RecruitingNCT07775625Updated Aug 20, 2026

Central Auditory Processing Modulation Underlying Anxiety Reduction Using Clinically Designed Improvisatory Music

An interventional study of Clinically Designed Improvisatory Music and Listening to Storytelling in Alzheimer's Disease, sponsored by Northwestern University. Recruiting at 1 site in United States. Open to participants aged 55 Years and older. Per ClinicalTrials.gov, last updated 2026-08-20.

Sponsored by Northwestern University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 6 months after the study started (first participant enrolled Feb 2026, registered Aug 2026).
  • Started Feb 2026; still recruiting 9 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
55 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 16 studies in Alzheimer Disease by Northwestern University — 5 open to participants now, 6 under way, none of them phase 3. Alzheimer Disease · Northwestern University.

Planned enrollment
12th of 15
30 · median 105
Started
2026
with 2 others
No phase
14 of 16
5 open now
Registered
15th of 16
by date

Among the 16 studies in Alzheimer Disease by Northwestern University, this one is the 12th largest by planned enrollment of the 15 interventional ones that give a count, is one of 3 that started in 2026, is one of 14 with no phase, and was the 15th registered.

Alzheimer Disease

3,967 studies on the registry are indexed under Alzheimer Disease; 928 are open to participants now.

Browse Alzheimer Disease studies →

Open to participants now

5 of the 16 studies in Alzheimer Disease by Northwestern University are open now, in 1 country. Recruiting first, the newest first:

By country, each count listing its studies:

All 5 open studies →

Where they have run

Who these studies take

Of the 642 Alzheimer Disease studies recruiting now, 283 (44%) set no upper age limit and 55 (9%) stop at 75 or younger; 34 take children under 18; 284 take healthy volunteers.

This study: 55 Years and older · all sexes · no healthy volunteers.

The full table on the hub →

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 16 studies in Alzheimer Disease by Northwestern University, or all of them as a file.
02

Study 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.

03

Conditions studied

  • Alzheimer's Disease

Keywords

  • Music-based intervention
  • Anxiety
  • Alzheimer's disease
04

Who can participate

Ages eligible
55 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria

  • Significant hearing impairments
  • Major comorbidities Beck Depression Inventory (BDI) scores above > 10'
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

MMSE and MoCA

Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Single group
Masking
Single (Outcomes assessor)
Enrollment
30 participants (estimated)

Study arms

  • Experimental
    Clinically Designed Improvisatory Music

    Other: Clinically Designed Improvisatory Music

  • Active comparator
    Listening to storytelling

    Other: Listening to Storytelling

Interventions

  • OtherClinically 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.

  • OtherListening to Storytelling

    Participants will listen to calming short stories within 30 minutes.

06

What researchers measure

Primary outcomes

  1. Rating Anxiety in Dementia (RAID)

    RAID is a structured clinical scale measuring anxiety in dementia. It will be evaluated 3 times, 4 weeks apart.

    Time frame: From enrollment to the end of treatment at 8 weeks.

Secondary outcomes

  1. Frequency Following Response (FFR)

    FFR is a scalp-recorded neural measure capturing precise subcortical encoding of sound timing, frequency, and speech acoustics.

    Time frame: It will be evaluated at baseline and up to a week after intervention.

  2. Heart rate

    Heart rate per minute

    Time frame: Measured at baseline up to a week after intervention.

  3. Blood pressure

    Blood pressure measured using a blood pressure machine.

    Time frame: Measured at baseline up to a week after intervention.

  4. Respiratory Rate

    Number of respirations per minutes.

    Time frame: Measured at baseline and up to a week after intervention.

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Feb 2026 (actual). Primary completion is estimated for Dec 2026, 10 months after the start.

Of 882 non-industry interventional studies with no phase under Alzheimer Disease, half reached primary completion within 30 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 51. This study's planned 10 months is below that.

Counting every sponsor, half of 959 studies reached it within 29 months; a quarter within 15 and three quarters within 51.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 9, 2026
First posted
Aug 20, 2026
StartActual
Feb 2, 2026
Primary completionEst.
Dec 15, 2026
CompletionEst.
Dec 15, 2026
Last update
Aug 20, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 20, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07775625
Responsible party
Borna Bonakdarpour (Associate Professor of Neurology, Northwestern University) — Principal investigator
First posted
Aug 20, 2026
Start date
Feb 2, 2026
Primary completion
Dec 15, 2026 (estimated)
Completion
Dec 15, 2026 (estimated)
Last update
Aug 20, 2026

Study contacts

Borna Bonakdarpour - Associate Professor, MD, FAAN, FANA
Contact
bbk@northwestern.edu
(312) 503-5170

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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