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Quality of life and Paracetamol In advanced Dementia

Paracetamol to enhance quality of life and daily function and to decrease care dependency in advanced dementia: A randomized, double-blind, placebo-controlled crossover trial in long-term care facilities

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON24190
Enrollment
95
Registered
2017-10-20
Start date
2018-01-01
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced dementia, Quality of Life, Paracetamol, long-term care facility Gevorderde dementie, Kwaliteit van leven, Paracetamol, verpleeghuis

Interventions

Subjects will receive either orally administered paracetamol at a maximum dose of 3 grams (3 x 2 tablets of 500 mg each) daily for 4 weeks, followed by 2 weeks 2.5 grams, according to recent protocols

Sponsors

Leiden University Medical Center (LUMC)
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Diagnosis of dementia, Reisberg Global Deterioration Scale 5-7 Age 65 years or older QUALIDEM (Quality of life) score below the expected median score of 70) Not using any pain medication one week before start study. Residents with PRN prescribed paracetamol ("as needed") are also eligible, if the use of paracetamol in the last week was not more than 1 gram/day and less than 3 grams/week

Exclusion criteria

Exclusion criteria: Presence of a severe psychiatric disorder, Severe liver insufficiency/disease, Use of >4 units alcohol per day, Allergy to study drugs, Concomitant use of flucloxacillin, carbamazepine, fenytoïne, fenobarbital, isoniazide and/or rifampicine, Weight < 50 kg

Design outcomes

Primary

MeasureTime frame
Quality of life: QUALIDEM, DS-DAT

Secondary

MeasureTime frame
Neuropsychiatric symptoms of dementia (NPI-NH) ADL functioning (Katz-15) Care dependency (CDS) Pain (MOBID-2) Medication use

Contacts

Public ContactP.H. Dam, van

Department of Public Health and Primary Care, Postzone V-0-P

QPID@lumc.nl071-5268640

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)