Safety and Efficacy of Divalproex and Quetiapine in Elderly Alzheimer's Dementia Patients

NCT00375557 | Withdrawn Phase 4

• 1 other identifier: 06-08-25-06
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The primary aim is to determine whether Divalproex ER or one of the atypical antipsychotics is more effective improving dementia related behavioral symptoms in patients with dementia, and evaluate the impact of such improvements on other clinical domains, such as quality of life, functional status.

Conditions

Alzheimer's Disease; Dementia; Behavioral Symptoms

Outcome Measures

Primary Outcomes (1)

• The change from the Baseline to the End of the Study/Early Termination visit in the CMAI & Quality of life scale scores.

  6 weeks

Study Arms (2)

1

ACTIVE COMPARATOR

Quetiapine

Drug: Quetiapine

2

ACTIVE COMPARATOR

Divalproex ER

Drug: Divalproex ER

Interventions

Divalproex ER DRUG

Divalproex ER will be initiated on 250 mg/day, dosed once daily. The daily dose of Divalproex ER will be titrated up 250 mg each day based on patients' response and tolerability, not to exceed a maximum of 2000 mg/day.

Also known as: Depakote ER

2

Quetiapine DRUG

Quetiapine will be initiated in 25 mg/day, with a variable dosing frequency (QD-TID). The daily dose of Quetiapine will be titrated up by 25-50 mg each day based on patients' response and tolerability, not to exceed a maximum of 750 mg/day.

Also known as: Seroquel

1

Eligibility Criteria

• Age: 55 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients, men and women =/\> 55 years of age.
• Inpatient / Outpatients with diagnosis of Moderate to Severe probable Alzheimer's dementia as determined by the Structured Clinical Interview for DSM-IV.
• Patients with a Mini Mental Status Examination scores between 3-15 at screening.
• Patients and Care Giver/ Legal representative or Guardian who are able to comprehend and satisfactorily comply with protocol requirements.
• Patient, Care Giver/ Legal representative or Guardian who signed the written informed consent given prior to entering any study procedure.
• Patients who have been at least three month ongoing stable dose of cholinesterase enzyme inhibitors or memantine.

You may not qualify if:

• Patients with a concurrent DSM-IV Axis I diagnosis in any of the following categories:
• Delirium, Amnestic and other Cognitive disorders 1.2. Lifetime Schizophrenia and other Psychotic Disorders 1.3. Lifetime Bipolar I Disorder 1.4. Bipolar 11 Disorder with an episode of hypomania within the last year 1.5. Alcohol or Substance Dependence or Abuse (excluding nicotine) in one month prior to the Screening Visit
• Patients with a history of intolerance or hypersensitivity to Divalproex ER \& Quetiapine.
• Patients who have a history of seizures.
• Patients who based on history or mental status examination have a significant risk of committing suicide.
• Patients who are homicidal or violent and who are in the Investigator's opinion in significant imminent risk of hurting others.
• Patients who have been treated with depot-neuroleptic within 3 months prior to the Baseline Visit.
• Patients with a positive urine drug screen, unless proven to be prescribed for a short-term course of treatment. In these situations a urine drug screen must be repeated at least 7 days after the last dose of the prescription medication containing narcotics.
• Patients who have participated in any clinical trial within one month prior to the Screening Visit, or in a clinical trial involving a psychotropic medication within the 3 months prior to the Screening Visit.
• Patients who have a medical condition that, in the Investigator's opinion, would expose them to an increased risk of a significant adverse event or interfere with assessments of safety and efficacy during the course of the trial.
• Patients with any current malignancy, or any clinically significant hematological, endocrine, cardiovascular, renal, hepatic, gastrointestinal or neurological disease (including any form of epilepsy). If there is a history of such disease but the condition has been stable for at least the past year and is judged by the investigator not to interfere with the patient's participation in the study, the patient may be included.
• Patients with systolic blood pressure greater than 180 mm Hg or less than 90 mm Hg or diastolic blood pressure greater than 105 mm Hg or less than 50 mm Hg at the Screening visit.
• Patients who test positive for Hepatitis B surface antigen or Hepatitis C antibody.
• Patients whose laboratory values at the Screening visit will be 1.5 times greater than ULN.
• Patients requiring concomitant treatment with any psychotropic drug (except zolpidem for sleep no more than 3x/week prn).

Sponsors & Collaborators

• University of Cincinnati: lead
• Abbott: collaborator

Study Sites (1)

Cincinnati VA Hospital

Cincinnati, Ohio, 45220, United States

Location

Related Publications (1)

• Profenno LA, Jakimovich L, Holt CJ, Porsteinsson A, Tariot PN. A randomized, double-blind, placebo-controlled pilot trial of safety and tolerability of two doses of divalproex sodium in outpatients with probable Alzheimer's disease. Curr Alzheimer Res. 2005 Dec;2(5):553-8. doi: 10.2174/156720505774932205.

  PMID: 16375658 BACKGROUND

MeSH Terms

Conditions

Alzheimer Disease; Dementia; Behavioral Symptoms

Interventions

Valproic Acid; Quetiapine Fumarate

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Behavior

Intervention Hierarchy (Ancestors)

Pentanoic Acids; Valerates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Fatty Acids, Volatile; Fatty Acids; Lipids; Dibenzothiazepines; Thiazepines; Thiepins; Sulfur Compounds; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Muhammad Aslam, MD

  University of Cincinnati/ VA Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: September 11, 2006
• First Posted: September 13, 2006
• Study Start: October 1, 2006
• Study Completion: September 1, 2007
• Last Updated: May 27, 2015

Record last verified: 2015-05

Locations

US (1)