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Donepezil Treatment of Psychotic Symptoms in Dementia Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00190021
Recruitment Status : Unknown
Verified October 2005 by Beersheva Mental Health Center.
Recruitment status was:  Not yet recruiting
First Posted : September 19, 2005
Last Update Posted : September 8, 2010
Information provided by:
Beersheva Mental Health Center

Brief Summary:

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 or disease Intervention/treatment Phase
Dementia of Alzheimer Type Drug: donepezil Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
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

Primary Outcome Measures :
  1. Possitive and Negative Syndrome Scale
  2. Clinical Global Impression

Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years to 90 Years   (Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00190021

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Contact: Vladimir Lerner, MD, PhD 9728-6401408
Contact: Tzvi Dwolatzky, MD 9728-6401416

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Beersheva Mental Health Center
Beersheva, Israel
Contact: Vladimr Lerner, MD, PhD    9728-6401408   
Contact: Tzvi Dwolatzky, MD    9728-6401416   
Sponsors and Collaborators
Beersheva Mental Health Center
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Principal Investigator: Valdimir Lerner, MD, PhD Ben-Gurion University of the Negev
Principal Investigator: Tzvi Dwolatzky, MD Ben-Gurion University of the Negev
Layout table for additonal information Identifier: NCT00190021    
Other Study ID Numbers: BMHC-3495CTIL
First Posted: September 19, 2005    Key Record Dates
Last Update Posted: September 8, 2010
Last Verified: October 2005
Keywords provided by Beersheva Mental Health Center:
Alzheimer's type dementia
Additional relevant MeSH terms:
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Alzheimer Disease
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders
Neurodegenerative Diseases
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Nootropic Agents