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Clinically Designed Improvisatory Music / Alzheimer's Disease / Listening to Storytelling · Interventional Study
ClinicalTrials.gov · August 20, 2026
Early or partial results. Treat as a signal, not a conclusion.
This is a protocol for a small randomized pilot trial comparing Clinically Designed Improvisatory Music (CDIM) to storytelling control in 30 people with Alzheimer's disease and anxiety, with the goal of assessing feasibility, safety, and potential efficacy on anxiety and caregiver burden over 8 weeks. No results have been reported in this registry record. The study also aims to explore neurophysiological mechanisms via frequency-following response (FFR) of central auditory processing.
Interventional, Randomized, Single Group, Single masking, Treatment purpose. Alzheimer's Disease; age from 55 Years. Intervention: Clinically Designed Improvisatory Music. Compared with: Listening to storytelling — Active Comparator. n = 30. 1 site: United States.
This is a protocol for a small randomized pilot trial comparing Clinically Designed Improvisatory Music (CDIM) to storytelling control in 30 people with Alzheimer's disease and anxiety, with the goal of assessing feasibility, safety, and potential efficacy on anxiety and caregiver burden over 8 weeks. No results have been reported in this registry record. The study also aims to explore neurophysiological mechanisms via frequency-following response (FFR) of central auditory processing.
Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.
Results when available may inform whether CDIM is a feasible, safe non-pharmacological option for anxiety in Alzheimer's disease and whether central auditory processing mediates its effect. Currently, no clinical impact can be assessed as results are not yet reported.
This is a registered trial protocol with no results reported; it is a pilot study designed to assess feasibility and generate hypothesis about a music intervention in Alzheimer's disease with anxiety.
As stated by the source record.
Quoted from the source exactly as published.
Results when available may inform whether CDIM is a feasible, safe non-pharmacological option for anxiety in Alzheimer's disease and whether central auditory processing mediates its effect. Currently, no clinical impact can be assessed as results are not yet reported.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.
Registry record from ClinicalTrials.gov (NCT07775625). This is a study registration, not published results. Lead sponsor: Northwestern University. Recruitment status: RECRUITING. Phase: NA. Study type: INTERVENTIONAL. Enrollment: 30 participants (ESTIMATED). Conditions: Alzheimer's Disease. Interventions: OTHER: Clinically Designed Improvisatory Music; OTHER: Listening to Storytelling. Primary outcome measures: Rating Anxiety in Dementia (RAID) , From enrollment to the end of treatment at 8 weeks.. 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.
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