CompletedPhase 2 / PHASE3

Pain in Patients With Dementia and Behavioural Disturbances

The Impact of Pain on Behavioural Disturbances in Patients With Moderate and Severe Dementia. A Cluster Randomized Trial

Lead sponsor

University of Bergen

Assets

Acetaminophen / Buprenorphine plaster / Morphine / Pregabalin

Listed sites

Recruiting sites

Enrollment

352

actual

Study population

Mixed / unspecified dementia

Key I/E criterion

•Age ≥65

Primary endpoint

•Cohen-Mansfield Agitation Inventory - long form (CMAI)

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

Org study ID2008-007490-20

NCT IDNCT01021696

Timeline

Milestones

Study start2009-11 (month precision)

Study first posted2009-11-30estimated

Primary completion2010-07actual (month precision)

Study completion2010-10actual (month precision)

Last update posted2011-08-10estimated

Assets

Drug assets

Acetaminophen Buprenorphine plaster Morphine Pregabalin

Study populations

Who this study enrolls

Mixed / unspecified dementia

Eligibility

Who can enroll

Minimum age65 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Aged 65 and older

•Residing in the NHs for at least 4 weeks

•Dementia according to Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) (American Psychiatric Association 1994), FAST score > 4 (Hughes 1982).

•Clinically relevant BPSD, operationally defined as CMAI score ≥ 39 or higher or/and at least one week history of agitation or aggression (Koss 1997).

•Written, informed consent provided by the participant (if they have capacity) or assent (if they do not have capacity) and a written proxy informed consent from a legally authorized representative empowered to make health-related decisions for the potential study participant

Exclusion criteria

•Clinician responsible for care, or study clinician considers that the patient suffers from any physical condition, which would make participation in the trial distressing or likely to increase suffering

•Advanced severe medical disease/disorder with expected survival less than 6 months or that could interfere with participation

•Psychosis or other severe mental disorder prior to dementia diagnosis;

•Severe aggression (≥8) on item 3 of the NPI subscale, with aggression as the predominant symptom

•Schizophrenia, schizoaffective disorder and bipolar disorder

•Uncontrolled epilepsy

•Severe liver impairment

•Renal failure, as measured by or equivalent to an estimated creatinine clearance of < 50mL/min/1.73m,

•Severe injury or anaemia (Hb < 8.5 mmol/l), comatose state, current enrolment in another experimental protocol.

•Known allergy or adverse reaction to Paracetamol, Morphine ret, Buprenorphine plaster or pregabalin

Endpoints (7)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Behavior / neuropsychiatric

Global cognition

Caregiver / quality of life

Safety / tolerability / PK

Global cognition

2 endpoints

Secondary/protocol endpoint

Mini Mental State Examination

Time frame:Screening/clinical investigation and week 8

Mini-Mental State Examination (MMSE)

ratio, descriptive

Secondary/protocol endpoint

Functional Assessment Staging (FAST)

Time frame:Screening and week 8

categorical status, descriptive

Behavior / neuropsychiatric

3 endpoints

Primary/protocol endpoint

Cohen-Mansfield Agitation Inventory - long form (CMAI)

Time frame:CMAI will be used during the screening/inclusion process, at week 2, 4, 8, and 12.

event count, event

Secondary/protocol endpoint

Neuropsychiatric Inventory - Nursing Home Version (NPI-NH)

Time frame:NPI will be used during the inclusion process, at week 2, 4, 8, and 12.

Neuropsychiatric Inventory (NPI)

event count, event

Secondary/protocol endpoint

Mobilisation-Observation-Behavior-Intensity-Dementia-2 (MOBID-2) Pain Scale

Time frame:Screening/clinical investigation, week 2,4,8,12

ratio, descriptive

Caregiver / quality of life

1 endpoint

Secondary/protocol endpoint

Activity of Daily Living function (ADL)

Time frame:ADL assessment will be used during clinical investigation related to the inclusion prosess and at week 8

ratio, descriptive

Safety / tolerability / PK

1 endpoint

Secondary/protocol endpoint

Adverse events (AE) and serious adverse event (SAE)

Time frame:week 2,4,8

event count, event

Publications (10)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 21, 2026

Endpoint classificationDelfa ADRD endpoint taxonomy

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.