Alzheimer's DiseaseNCT07775625
Central Auditory Processing Modulation Underlying Anxiety Reduction Using Clinically Designed Improvisatory Music
A study testing Clinically Designed Improvisatory Music and Listening to Storytelling in people with Alzheimer's Disease, run by Northwestern University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Alzheimer's Disease
- What is being tested?
- Clinically Designed Improvisatory Music and Listening to Storytelling
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Feb 2026to 15 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Significant hearing impairments
- Major comorbidities Beck Depression Inventory (BDI) scores above > 10'
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Northwestern University Feinberg School of Medicine
Chicago, Illinois, 60611
About this study
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.
Read more
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
- Being tested
- Clinically Designed Improvisatory Music, Listening to Storytelling
- Keywords
- Music-based intervention, Anxiety, Alzheimer's disease
- Medical subject headings
- Alzheimer Disease, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinically Designed Improvisatory MusicOther
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 StorytellingOther
Participants will listen to calming short stories within 30 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Clinically Designed Improvisatory Music | Experimental | Not described Receives: Other: Clinically Designed Improvisatory Music |
| Listening to storytelling | Active comparator | Not described Receives: Other: Listening to Storytelling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rating Anxiety in Dementia (RAID)
RAID is a structured clinical scale measuring anxiety in dementia. It will be evaluated 3 times, 4 weeks apart.
Measured: From enrollment to the end of treatment at 8 weeks.
Secondary outcomes (4)
Frequency Following Response (FFR)
FFR is a scalp-recorded neural measure capturing precise subcortical encoding of sound timing, frequency, and speech acoustics.
Measured: It will be evaluated at baseline and up to a week after intervention.
Heart rate
Heart rate per minute
Measured: Measured at baseline up to a week after intervention.
Blood pressure
Blood pressure measured using a blood pressure machine.
Measured: Measured at baseline up to a week after intervention.
Respiratory Rate
Number of respirations per minutes.
Measured: Measured at baseline and up to a week after intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2026
- Study start2 Feb 2026
- Primary completion15 Dec 2026 (estimated)
- Study completion15 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer's DiseaseStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Borna Bonakdarpour, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07775625
- Sponsor's protocol ID
- STU00215983-MOD0004
- Status last verified
- Aug 2026
- First submitted
- 9 Aug 2026
- Last updated
- 20 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Central Auditory Processing Modulation Underlying Anxiety Reduction Using Clinically Designed Improvisatory Music
- ClinicalTrials.gov ID
- NCT07775625
- Acronym / sponsor ID
- STU00215983-MOD0004
- Conditions
- Alzheimer's Disease
- Keywords
- Music-based intervention, Anxiety, Alzheimer's disease
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Study start
- 2 Feb 2026 (actual)
- Primary completion
- 15 Dec 2026 (estimated)
- Study completion
- 15 Dec 2026 (estimated)
- First posted
- 20 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Clinically Designed Improvisatory Music | Experimental | Other: Clinically Designed Improvisatory Music |
| Listening to storytelling | Active comparator | Other: Listening to Storytelling |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Significant hearing impairments
- Major comorbidities Beck Depression Inventory (BDI) scores above > 10'
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clinically Designed Improvisatory MusicClinically 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. | Other | Clinically Designed Improvisatory Music |
| Listening to StorytellingParticipants will listen to calming short stories within 30 minutes. | Other | Listening to storytelling |
Primary outcome
Rating Anxiety in Dementia (RAID)
Time frame: From enrollment to the end of treatment at 8 weeks.
RAID is a structured clinical scale measuring anxiety in dementia. It will be evaluated 3 times, 4 weeks apart.
4 secondary outcomes
Frequency Following Response (FFR)
Time frame: It will be evaluated at baseline and up to a week after intervention.
Heart rate
Time frame: Measured at baseline up to a week after intervention.
Blood pressure
Time frame: Measured at baseline up to a week after intervention.
Respiratory Rate
Time frame: Measured at baseline and up to a week after intervention.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2026.
- NU MDRN CITATIONS PDF FILELink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Clinically Designed Improvisatory Music and Listening to Storytelling in people with Alzheimer's Disease, run by Northwestern University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Borna Bonakdarpour - Associate Professor, MD, FAAN, FANA ((312) 503-5170, bbk@northwestern.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rating Anxiety in Dementia (RAID) (time frame: From enrollment to the end of treatment at 8 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2026.