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Anti-epileptic drug

Depakote for Dementia

Q: How can I sign up to be a participant in this research project?

<p>For this study on <a href="https://www.withpower.com/clinical-trials/dementia">dementia</a>, we are looking for 20 participants that are 60 years old or younger. To be eligible, potential patients must meet the following conditions: There must be nursing staff reports or a CMAI score > 4 on one item, the candidate may be taking psychotropic medication (such as antidepressants or antipsychotics), and the MMSE score must be > 7.</p>

Phase 1

Waitlist Available

Led By Mark Vanelli, MD

Research Sponsored by Hearthstone Alzheimer Care

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age > or = 60 years

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Study Summary

This trial will study whether the drug Depakote can reduce symptoms of agitation and aggression in patients with scores above the normal range on those symptoms. The trial will also study side effects of the drug.

Who is the study for?

This trial is for individuals aged 60 or older with dementia, as diagnosed by DSM-IV criteria, who show behavioral disturbances. They must have a certain level of cognitive function (MMSE score >7) and exhibit significant agitation or aggression. Participants may continue using other psychotropic medications if already prescribed.Check my eligibility

What is being tested?

The study is examining whether Depakote can reduce verbal and physical agitation in dementia patients over six weeks without causing many side effects. Progress will be monitored using the Cohen-Mansfield Agitation Index and other clinical assessments at different stages of the trial.See study design

What are the potential side effects?

While not detailed here, Depakote could potentially cause side effects such as nausea, drowsiness, dizziness, hair loss, changes in weight or appetite, liver damage (monitored via tests), and impact on blood cell counts.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am 60 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Blood levels of effective dose

Change from baseline on CMAI sub-scales

Secondary outcome measures

Adverse effects and tolerability

Change from baseline on CGI and NPI

Dosing information on Concomitant psychotropic medications

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Hearthstone Alzheimer CareLead Sponsor

1 Previous Clinical Trials

182 Total Patients Enrolled

1 Trials studying Dementia

182 Patients Enrolled for Dementia

AbbottIndustry Sponsor

751 Previous Clinical Trials

478,155 Total Patients Enrolled

3 Trials studying Dementia

70 Patients Enrolled for Dementia

Mark Vanelli, MDPrincipal InvestigatorHearthstone Alzheimer Care

Media Library

Depakote (Anti-epileptic drug) Clinical Trial Eligibility Overview. Trial Name: NCT00197834 — Phase 1

Dementia Clinical Trial 2023: Depakote Highlights & Side Effects. Trial Name: NCT00197834 — Phase 1

Depakote (Anti-epileptic drug) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00197834 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

This research is only open to those under 30, correct?

"The target age range for this clinical study are individuals who are over 60 and under 0."

Answered by AI

How can I sign up to be a participant in this research project?

"For this study on dementia, we are looking for 20 participants that are 60 years old or younger. To be eligible, potential patients must meet the following conditions: There must be nursing staff reports or a CMAI score > 4 on one item, the candidate may be taking psychotropic medication (such as antidepressants or antipsychotics), and the MMSE score must be > 7."

Answered by AI

Does this drug have FDA backing?

"This is a Phase 1 trial, which means that there is limited data supporting the safety and efficacy of the treatment. Our team at Power have given it a safety rating of 1."

Answered by AI

Are people with the qualifying condition able to join the trial at this time?

"Unfortunately, this particular trial is not currently recruiting new patients. Although the last update was on August 10th, 2006, there are many other trials – 393 in total – that are still open to participants."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Study of Depakote for Behavioral and Psychological Symptoms in Dementia

2004. "Study of Depakote for Behavioral and Psychological Symptoms in Dementia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT00197834.

All > Dementia > Psychological