Eligibility, any sex, with Dementia. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Frequency of Agitated and Aggressive Behaviors (Staff Report)Primary· 4-months
The tool used to interview staff about resident behaviors is the Cohen-Mansfield Agitation Inventory. Research staff interview a nursing staff member who knows the resident well to ask how frequently 29 agitated and/or aggressive behaviors occurred in the past week. There are seven response choices for each item, anchored from never (1) to several times per hour (7). Total scores on the Cohen-Mansfield Agitation Inventory range from 29 to 203, with higher scores representing more frequent agitated and/or aggressive behaviors. Adjusted mean overall scores will be compared for treatment and cont
Group
Value
95% CI
Music and Memory
50.31
± 1.35
Usual Care
48.04
± 1.35
Frequency of Verbal Agitated and Aggressive Behaviors (Direct Observation)Secondary· 4-months
The tool used to directly observe resident behaviors is the Agitation Behavior Mapping Instrument. Research staff observe residents for short intervals (3 minutes per observation) and record the number of times 14 specific verbally and physically agitated behaviors occurred (up to 10 times per observation). Ordinal outcomes quantify the number of physical and verbal agitated behaviors that occurred during the ABMI observations. The levels of these outcomes are None (0), Some (1 - 3) and Many (4 or more) observed behaviors.
None
Group
Value
95% CI
Music and Memory
0.80
0.74 – 0.85
Usual Care
0.80
0.74 – 0.85
Some
Group
Value
95% CI
Music and Memory
0.13
0.09 – 0.17
Usual Care
0.13
0.10 – 0.17
Many
Group
Value
95% CI
Music and Memory
0.08
0.06 – 0.10
Usual Care
0.07
0.03 – 0.09
Frequency of Agitated and Aggressive Behaviors (Administrative Data)Secondary· 4-months
The Aggressive Behavior Scale is a 4-item measure describing the frequency of physical behavioral symptoms directed toward others; verbal behavioral symptoms directed toward others; other behavioral symptoms not directed toward others; and behaviors related to resisting necessary care. For each item, frequency in the past week is reported as: behavior not exhibited (0); behavior occurred 1-3 days (1); behavior occurred 4-6 days (2); or behavior occurred daily (3). The Aggressive Behavior Scale ranges from 0 to 12, with higher scores indicating more frequent agitated and/or aggressive behaviors
Group
Value
95% CI
Music and Memory
0.42
± 0.08
Usual Care
0.40
± 0.08
Antipsychotic UseSecondary· 4-months
Any antipsychotic use in the past week, based on Minimum Data Set (standardized assessment of nursing home residents). Measure type of mean is chosen based on adjusted percentage with standard errors from a multilevel, difference in difference regression models.
Group
Value
95% CI
Music and Memory
26.2
± 1.4
Usual Care
29.6
± 1.3
Antianxietal UseSecondary· 4-months
Any antianxietal use in the past week, based on Minimum Data Set (standardized assessment of nursing home residents). Measure type of mean is chosen based on adjusted percentage with standard errors from a multilevel, difference in difference regression models.
Group
Value
95% CI
Music and Memory
20.8
± 1.5
Usual Care
24.3
± 1.7
Antidepressant UseSecondary· 4-months
Any antidepressant use in the past week and days of use in the past week, based on Minimum Data Set (standardized assessment of nursing home residents). Measure type of mean is chosen based on adjusted percentage with standard errors from a multilevel, difference in difference regression models.
Group
Value
95% CI
Music and Memory
57.5
± 1.5
Usual Care
58.8
± 1.5
Hypnotic UseSecondary· 4-months
Any hypnotic use in the past week, based on Minimum Data Set (standardized assessment of nursing home residents). Comparison of percent with any use will be compared for treatment and control populations.
Group
Value
95% CI
Music and Memory
0.83
Usual Care
1.22
DepressionSecondary· 4-months
The Patient Health Questionnaire is a 9-item screening assessment for depression severity. For each item, respondents indicate the frequency of the symptom in the past 2 weeks using the following choices: never or one day (0); 2-6 days (1); 7-11 days (2); or 12-14 days (3). Total scores range from 0 to 27, with higher scores indicating more frequent depressive symptoms. Average total scores will be compared for treatment and control populations.
Group
Value
95% CI
Music and Memory
2.09
± 0.33
Usual Care
2.30
± 0.33
Frequency of Physical Agitated and Aggressive Behaviors (Direct Observation)Secondary· 4-months
The tool used to directly observe resident behaviors is the Agitation Behavior Mapping Instrument. Research staff observe residents for short intervals (3 minutes per observation) and record the number of times 14 specific verbally and physically agitated behaviors occurred (up to 10 times per observation). We report the proportion of participants with no behaviors, some behaviors (1-3 ), many behaviors (4+)
None
Group
Value
95% CI
Music and Memory
0.85
0.80 – 0.90
Usual Care
0.90
0.85 – 0.94
Some
Group
Value
95% CI
Music and Memory
0.12
0.08 – 0.17
Usual Care
0.09
0.06 – 0.13
Many
Group
Value
95% CI
Music and Memory
0.03
0.02 – 0.04
Usual Care
0.01
0.01 – 0.02
Observed PleasureSecondary· 4-months
The Observed Emotion Rating Scale is completed by a trained observer to document duration of five observed emotional states (pleasure, anger, anxiety / fear, sadness, and general alertness) during short observations (3 minutes per observation). For each emotional state, the researcher indicates whether or not the emotion was observed: never (1); less than 16 seconds (2); 16-59 seconds (3); 1-2 minutes (4); or 3+ minutes (5). Total scores range from 5 to 25, with higher scores indicating greater duration of observed emotion. We report the proportion of participants with any observed emotion dur
Group
Value
95% CI
Music and Memory
0.36
0.30 – 0.43
Usual Care
0.29
0.24 – 0.35
Observed AngerSecondary· 4-months
The Observed Emotion Rating Scale is completed by a trained observer to document duration of five observed emotional states (pleasure, anger, anxiety / fear, sadness, and general alertness) during short observations (3 minutes per observation). For each emotional state, the researcher indicates whether or not the emotion was observed: never (1); less than 16 seconds (2); 16-59 seconds (3); 1-2 minutes (4); or 3+ minutes (5). Total scores range from 5 to 25, with higher scores indicating greater duration of observed emotion. Average observed emotion scores will be compared for treatment and con
Group
Value
95% CI
Music and Memory
0.04
0.03 – 0.06
Usual Care
0.03
0.02 – 0.04
Observed SadnessSecondary· 4-months
The Observed Emotion Rating Scale is completed by a trained observer to document duration of five observed emotional states (pleasure, anger, anxiety / fear, sadness, and general alertness) during short observations (3 minutes per observation). For each emotional state, the researcher indicates whether or not the emotion was observed: never (1); less than 16 seconds (2); 16-59 seconds (3); 1-2 minutes (4); or 3+ minutes (5). Total scores range from 5 to 25, with higher scores indicating greater duration of observed emotion. Average observed emotion scores will be compared for treatment and con
Group
Value
95% CI
Music and Memory
0.07
0.05 – 0.11
Usual Care
0.06
0.04 – 0.10
Sponsor's own description
The purpose of this trial is to test the effects of a personalized music intervention (Music and Memory, Inc.) on agitated and aggressive behaviors for nursing home residents with dementia.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT07531589 — BrainLive Connect: Non-professional Delivered CST for People Living With Dementia
· NA
· recruiting
NCT07290387 — Tele-Savvy for Latino Caregivers
· NA
· recruiting
NCT06088810 — The Impact of Music Intervention on Sleep
· NA
· recruiting
NCT07482800 — Dementia in Fiction and Clinical Narratives
· recruiting
NCT07392944 — Multicomponent Exercise Program on Physical Function, Cognition and Falls Risk Among Older Adults Living in Nursing Home
· NA
· recruiting
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Brown University
Last refreshed: 28 February 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03821844.