Alzheimer disease and antipsycotics: a long term multicenter randomized clinical trial - AdCare

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

1. Patients with a diagnosis of probable Alzheimer?s Disease (AD), according to the National Institute of Neurological and Communicative Diseases and Stroke/Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria, with a MMSE between 5 and 26 (included), able to walk independently or with a stick, not living in a nursing home and assisted by a caregiver. 2. Informed consent given by the patient or his/her legal representative and by the caregiver. 3. Presence of at least one of the following behavioural and psychological symptoms of clinically relevant severity and with a duration of at least one week: delusions, hallucinations, agitation, aggression. Clinically relevant severity is defined as a score > 4 in at least one of the first 18 sub-items of the BEHAVE-AD-FW scale, deriving from the product of a frequency score > 2 (2 = for many days) and a severity score ³ 2 (2 = presence of the symptom, generally accompanied by an emotional component). The onset of delusions and/or hallucinations and/or agitation and/or aggression must have occurred after the onset of the cognitive and functional deficit of AD. 4. Absence of vigilance and confusion fluctuations (Clinician Assessment of Fluctuation = 0).
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

Exclusion Criteria

1. Presence of elapsing curable diseases and/or pharmacological intoxications and/or environmental modifiable causes, potentially responsible for the onset of behavioural and psychological symptoms. 2. Absence of a reliable caregiver, with daily contacts with the patient. 3. Diagnosis of primary psychotic disorders preceding the diagnosis of dementia. 4. Presence of early onset Parkinsonism (e.g. before the cognitive symptoms or within one year since the onset of cognitive symptoms). 5. Serious postural instability defined as a score ≥ 3 to the 13th sub-item of the motor section of the Unified Parkinson?s Disease Rating Scale (UPDRS). 6. Presence of possible multi-infarct dementia (Hachinski ischemic score > 6). 7. Presence of serious hepatic, renal, cardio-vascular diseases and/or serious impairment of sight and hearing (chronic not controlled disease or seriously disabling) defined as a score ≥3 to the respective sub-items of Cumulative Illness Rating Scale (CIRS). 8. Presence of instable diseases that could potentially need acute treatments. 9. Hypersensitivity or absolute contraindication to one of the study treatments. 10. Treatment with typical or atypical antipsychotic drugs in the 3 month period preceding randomisation. 11. Treatment with benzodiazepines in the 3 month period preceding randomisation. Patients assuming benzodiazepines, as hypnotic drugs, continuously (since at least 6 months) can be included. 12. Treatment with antidepressant drugs in the 6 month period preceding randomisation. Patients assuming antidepressant non tricyclic drugs continuously and without dosage modifications since at least 8 weeks can be included. 13. Treatment with anticonvulsant drugs (even if used as mood stabilizers), antiparkinson drugs, corticosteroids, oral anticoagulants. 14. Patients who started treatment with acetylcholinesterase inhibitors or modified drug dosages in the 8 weeks preceding randomisation.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: evaluation of long term efficacy and safety of three atypical and one typical antipsycotic drugs in the treatment BPSD in Alzheimer patients;Secondary Objective: evaluation of time to discontinuation to treatment at 12 weeks during the treatment of three atypical and one typical antipsycotic drugs in the treatment BPSD in Alzheimer patients;Primary end point(s): discontinuation rate for lack of efficacy and response rate at 12 weeks, and the time to open-label within 20 weeks.

Secondary Outcome Measures