Dementia of Alzheimer Type | Donepezil Treatment of Psychotic Symptoms in Dementia Patients
Dementia of Alzheimer Type research study
What is the primary objective of this study?
Conventional psychotropic medications may be used to treat behavioral disturbances and psychotic symptoms in patients with dementia and they are the drugs of choice for treating delusions and hallucinations. However the sensitivity to side effects in these patients often restricts the use of these agents (2, 3). Although, atypical antipsychotics have some advantages compared with conventional neuroleptics, they also are associated with side effects (5, 6). Cholinesterase inhibitors (ChEIs) enhance neuronal transmission by increasing the availability of acetylcholine in muscarinic and nicotinic receptors. According to findings of some researchers ChEIs have psychotropic effects and may play an important role in controlling neuropsychiatric and behavioral disturbances in patients with Alzheimer's disease (7-10). These agents may also contribute to the management of other disorders with cholinergic system abnormalities and neuropsychiatric symptoms such as visual hallucinations (11). Donepezil is a piperidine-based reversible, noncompetitive ChEI, which is indicated in the management of patients with Alzheimer's disease of mild to moderate severity (12-14). Preliminary observations suggest the possible value of ChEIs in the amelioration of psychotic symptoms in patients with dementia of the Alzheimer's type (DAT), dementia with Lewy bodies and patients suffering from Parkinson's disease (11-18). The results of our study (18) indicate that the addition of donepezil to perphenazine resulted in qualitatively superior clinical gains compared to higher doses of neuroleptic therapy without donepezil. The finding of the pilot study although impressive, stem from data regarding a rather small sample. The present (second) phase of the study will include a larger sample of patients. We now intend to examine 80 inpatients, aged 65-90 years old, suffering from DAT.
Who is eligible to participate?
Inclusion Criteria: - age: 65-90 - DSM-IV diagnosis of Alzheimer's type dementia - inclusion of psychotic symptoms such as: hallucinations and delusions, aggression/agitation, irritability and disinhibition calling for adminstration of antipsychotic drugs - duration of psychotic symptoms of at least 2 weeks before start of treatment - lack of improvement of psychotic symptoms during perphenazine treatment for at least 3 weeks Exclusion Criteria: - vascular demential - concurrent Axis I DSM-IV diagnosis (delirium, schizophrenia, delusional disorder and affective disorders) - significant medical illness (cardiovascular, liver, renal, edocrinal, B12 or folic acid deficience and neurological illnesses) - drug or alcohol addiction
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Dementia of Alzheimer Type
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Phase: Phase 3
Primary Outcome: Possitive and Negative Syndrome Scale
Study sponsors, principal investigator, and references
Principal Investigator: Valdimir Lerner, MD, PhD
Lead Sponsor: Beersheva Mental Health Center