Donepezil Treatment of Psychotic Symptoms in Dementia Patients

The recruitment status of this study is unknown because the information has not been verified recently.

Verified October 2005 by Beersheva Mental Health Center.
Recruitment status was Not yet recruiting

Sponsor:

Information provided by:

Beersheva Mental Health Center

ClinicalTrials.gov Identifier:

NCT00190021

First received: September 11, 2005

Last updated: September 5, 2010

Last verified: October 2005

History of Changes

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-Blind Primary Purpose: Treatment
Official Title:	Donepezil as Add-On Treatment of Psychotic Symptoms in Patients With Dementia of the Alzheimer's Type

Resource links provided by NLM:

Genetics Home Reference related topics: Alzheimer disease

MedlinePlus related topics: Alzheimer's Disease Dementia Mental Disorders Psychotic Disorders

Drug Information available for: Donepezil hydrochloride Donepezil

Genetic and Rare Diseases Information Center resources: Familial Alzheimer Disease

U.S. FDA Resources

Further study details as provided by Beersheva Mental Health Center:

Primary Outcome Measures:

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)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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 Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00190021

Contacts


Contact: Vladimir Lerner, MD, PhD	9728-6401408	lernervld@yahoo.com
Contact: Tzvi Dwolatzky, MD	9728-6401416	tzvidov@bgu.ac.il

Locations


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

Sponsors and Collaborators

Beersheva Mental Health Center

Investigators


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
Health Authority:	Israel: Israeli Health Ministry Pharmaceutical Administration

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 September 28, 2016

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