Alzheimer's DiseasePhase 4NCT00375557
Safety and Efficacy of Divalproex and Quetiapine in Elderly Alzheimer's Dementia Patients
A Phase 4 study testing Divalproex ER and Quetiapine in people with Alzheimer's Disease and Dementia, run by University of Cincinnati at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 55 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Alzheimer's Disease, Dementia, Behavioral Symptoms
- What is being tested?
- Divalproex ER and Quetiapine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2006to Sep 2007
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Patients with a concurrent DSM-IV Axis I diagnosis in any of the following categories:
- 1.1. 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.
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- 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).
- Patients who require concomitant therapy with any prohibited prescription.
- Patients who are unable to speak, read, and understand English or are judged by the investigator to be unable or unlikely to follow the study protocol and complete all scheduled visits.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open Label, Randomized, Flexible Dose, 6-week Clinical Trial of the Safety and Efficacy of Divalproex ER vs Quetiapine in the Treatment of Behavioral Symptoms in the Elderly With Moderate to Severe Alzheimer's Dementia
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.
Read the detailed description
This clinical trial will be open label, flexible dose study of Divalproex ER vs Quetiapine for 6 weeks. Patients will be randomized to Divalproex ER vs Quetiapine outpatient / inpatient. The schedule of visits will include a screening, a baseline and 3 treatment visits / assessment. The End of Study/Early Termination visit will conclude the Trial. The safety follow-up visit will be scheduled only for the patients with unresolved Adverse Events detected prior or at the End of Study/Early Termination visit.
- Conditions
- Alzheimer's Disease, Dementia, Behavioral Symptoms
- Being tested
- Divalproex ER, Quetiapine
- Medical subject headings
- Alzheimer Disease, Dementia, Behavioral Symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Divalproex ERDrug
Also called Depakote ER
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.
QuetiapineDrug
Also called Seroquel
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.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Quetiapine Receives: Drug: Quetiapine |
| 2 | Active comparator | Divalproex ER Receives: Drug: Divalproex ER |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change from the Baseline to the End of the Study/Early Termination visit in the CMAI & Quality of life scale scores.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2006 (estimated)
- Study startOct 2006
- Study completionSep 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Alzheimer's DiseaseStudies of the same condition, open and under way.
- More trials run by University of CincinnatiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Cincinnati
- Sponsor type
- University, hospital or other
- Collaborators
- Abbott
- Responsible party
- Principal investigator, Muhammad Aslamm, University of Cincinnati
- Investigators
- Muhammad Aslam, MD, Principal investigator, University of Cincinnati/ VA Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00375557
- Sponsor's protocol ID
- 06-08-25-06
- Status last verified
- May 2015
- First submitted
- 11 Sep 2006
- Last updated
- 27 May 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 16375658
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Randomized, Flexible Dose, 6-week Clinical Trial of the Safety and Efficacy of Divalproex ER vs Quetiapine in the Treatment of Behavioral Symptoms in the Elderly With Moderate to Severe Alzheimer's Dementia
- ClinicalTrials.gov ID
- NCT00375557
- Acronym / sponsor ID
- 06-08-25-06
- Conditions
- Alzheimer's Disease, Dementia, Behavioral Symptoms
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of CincinnatiUniversity, hospital or other
- Collaborators
- Abbott
- Study start
- Oct 2006
- Study completion
- Sep 2007 (actual)
- First posted
- 13 Sep 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This clinical trial will be open label, flexible dose study of Divalproex ER vs Quetiapine for 6 weeks. Patients will be randomized to Divalproex ER vs Quetiapine outpatient / inpatient. The schedule of visits will include a screening, a baseline and 3 treatment visits / assessment. The End of Study/Early Termination visit will conclude the Trial. The safety follow-up visit will be scheduled only for the patients with unresolved Adverse Events detected prior or at the End of Study/Early Termination visit.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: QuetiapineQuetiapine |
| 2 | Active comparator | Drug: Divalproex ERDivalproex ER |
Who may qualify
- Ages
- 55 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (17 listed)
- Patients with a concurrent DSM-IV Axis I diagnosis in any of the following categories:
- 1.1. 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Divalproex ERAlso: Depakote ERDivalproex 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. | Drug | 2 |
| QuetiapineAlso: SeroquelQuetiapine 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. | Drug | 1 |
Primary outcome
The change from the Baseline to the End of the Study/Early Termination visit in the CMAI & Quality of life scale scores.
Time frame: 6 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2015.
- Background: PubMed 16375658Profenno 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Muhammad Aslam, MD principal investigator
University of Cincinnati/ VA Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Divalproex ER and Quetiapine in people with Alzheimer's Disease and Dementia, run by University of Cincinnati at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 27 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change from the Baseline to the End of the Study/Early Termination visit in the CMAI & Quality of life scale scores. (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00375557, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2015.