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.

Phase 1

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: 20.0Level: LLTClassification code 10066844Term: Behavioral and psychiatric symptoms of dementiaSystem Organ Class: 100000171288
Therapeutic area: Not possible to specify

Registration Number: EUCTR2017-000039-16-NL

Lead Sponsor: eiden University Medical Center

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

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

•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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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<br>at 6 weeks<br>at 7 weeks<br>at 13 weeks (end)

Secondary Outcome Measures

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