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Donepezil Treatment of Psychotic Symptoms in Dementia Patients
Recruitment status was: Not yet recruiting
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
| Dementia of Alzheimer Type | Drug: donepezil | Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Primary Purpose: Treatment |
| Official Title: | Donepezil as Add-On Treatment of Psychotic Symptoms in Patients With Dementia of the Alzheimer's Type |
- Possitive and Negative Syndrome Scale
- Clinical Global Impression
| Estimated Enrollment: | 80 |
Show Detailed Description
Eligibility| Ages Eligible for Study: | 65 Years to 90 Years (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT00190021
| Contact: Vladimir Lerner, MD, PhD | 9728-6401408 | lernervld@yahoo.com | |
| Contact: Tzvi Dwolatzky, MD | 9728-6401416 | tzvidov@bgu.ac.il |
| Israel | |
| Beersheva Mental Health Center | Not yet recruiting |
| Beersheva, Israel | |
| Contact: Vladimr Lerner, MD, PhD 9728-6401408 lernervld@yahoo.com | |
| Contact: Tzvi Dwolatzky, MD 9728-6401416 tzvidov@bgu.ac.il | |
| Principal Investigator: | Valdimir Lerner, MD, PhD | Ben-Gurion University of the Negev |
| Principal Investigator: | Tzvi Dwolatzky, MD | Ben-Gurion University of the Negev |
More Information
| ClinicalTrials.gov Identifier: | NCT00190021 History of Changes |
| Other Study ID Numbers: |
BMHC-3495CTIL |
| Study First Received: | September 11, 2005 |
| Last Updated: | September 5, 2010 |
Keywords provided by Beersheva Mental Health Center:
|
Alzheimer's type dementia donepezil double-blind |
Additional relevant MeSH terms:
|
Dementia Alzheimer Disease Brain Diseases Central Nervous System Diseases Nervous System Diseases Neurocognitive Disorders Mental Disorders Tauopathies Neurodegenerative Diseases |
Donepezil Cholinesterase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Cholinergic Agents Neurotransmitter Agents Physiological Effects of Drugs Nootropic Agents |
ClinicalTrials.gov processed this record on August 21, 2017