Donepezil Treatment of Psychotic Symptoms in Dementia Patients

NCT00190021 | Unknown Phase 3

• 1 other identifier: BMHC-3495CTIL
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Dementia of Alzheimer Type

Keywords

Alzheimer's type dementia; donepezil; double-blind

Outcome Measures

Primary Outcomes (2)

• Possitive and Negative Syndrome Scale

• Clinical Global Impression

Interventions

donepezil DRUG

Eligibility Criteria

• Age: 65 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• age: 65-90
• DSM-IV diagnosis of Alzheimer's type dementia
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Beersheva Mental Health Center: lead

Study Sites (1)

Beersheva Mental Health Center

Beersheva, Israel

Location

MeSH Terms

Interventions

Donepezil

Intervention Hierarchy (Ancestors)

Indans; Indenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Polycyclic Compounds

Study Officials

• Valdimir Lerner, MD, PhD

  Ben-Gurion University of the Negev

  PRINCIPAL INVESTIGATOR

• Tzvi Dwolatzky, MD

  Ben-Gurion University of the Negev

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Vladimir Lerner, MD, PhD

CONTACT

9728-6401408; lernervld@yahoo.com

Tzvi Dwolatzky, MD

CONTACT

9728-6401416; tzvidov@bgu.ac.il

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: September 11, 2005
• First Posted: September 19, 2005
• Last Updated: September 8, 2010

Record last verified: 2005-10

Locations

IL (1)