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.

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. - Quality of life and Paracetamol In advanced Dementia (Q-PID trial)

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2017-000039-16-NL

Enrollment

Unknown

Registered

2017-10-10

Start date

2017-10-10

Completion date

Unknown

Last updated

2017-10-23

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

Conditions

We will investigate the effect of regularly scheduled administration of paracetamol on Quality of life, daily functioning, care dependency, pain, change in challenging behaviour and antipsychotic medication use of long term care facility residents with moderate to severe dementia (of all types). MedDRA version: 20.0 Level: LLT Classification code 10066844 Term: Behavioral and psychiatric symptoms of dementia System Organ Class: 100000171288

Interventions

Trade Name: Paracetamol Pharmaceutical Form: Tablet Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use

Eligibility

Sex/Gender

All

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 less than 3 grams/week. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 95

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

Measure	Time frame
Main Objective: To evaluate the effect of regularly scheduled administration of paracetamol on quality of life of long term care facility residents with moderate to (very) severe dementia.;Secondary Objective: To evaluate the effect of paracetamol treatment on daily function and care dependency, pain, change in challenging behaviour and antipsychotic medication use in long term care facility residents with moderate to (very) severe dementia.;Primary end point(s): Difference in baseline quality of life (QUALIDEM-score) and follow-up scores;Timepoint(s) of evaluation of this end point: at Baseline at 6 weeks at 7 weeks at 13 weeks (end)	—

Measure

Time frame

Main Objective: To evaluate the effect of regularly scheduled administration of paracetamol on quality of life of long term care facility residents with moderate to (very) severe dementia.;Secondary Objective: To evaluate the effect of paracetamol treatment on daily function and care dependency, pain, change in challenging behaviour and antipsychotic medication use in long term care facility residents with moderate to (very) severe dementia.;Primary end point(s): Difference in baseline quality of life (QUALIDEM-score) and follow-up scores;Timepoint(s) of evaluation of this end point: at Baseline at 6 weeks at 7 weeks at 13 weeks (end)

—

Secondary

Measure	Time frame
Secondary end point(s): • Neuropsychiatric symptoms of dementia • ADL functioning • Care dependency • Dementia severity • Pain • Medication use All measurements above will be taken at baseline and compared with follow-up scores;Timepoint(s) of evaluation of this end point: at Baseline at 6 weeks at 7 weeks at 13 weeks (end)	—

Countries

Netherlands

Contacts

Public ContactQ-PID trial

Leiden University Medical Center

00310715268444

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026