Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:40 AM
Ignite Modification Date:
2025-12-25 @ 2:40 AM
NCT ID:
NCT00197834
Eligibility Criteria:
Inclusion Criteria:
* Diagnostic and Statistical Manual of Mental Disorders-Fourth Edition (DSM-IV) dementia diagnosis
* Age \> or = 60 years
* MMSE \> 7
* Clinical evidence of a behavioral disturbance as evidenced by nursing staff report or mean score of \> 4 on at least one CMAI item
* May be on and remain on co-prescribed psychotropic agents (e.g., antidepressants, atypical antipsychotics, acetylcholinesterase inhibitors)
Exclusion Criteria:
* Patients with schizophrenia, bipolar disorder, seizure disorder that are co-morbid with dementia
* Patients with delirium, or a poorly controlled medical illness
* MMSE \> 24
* Lack of a significant behavioral disturbance
* Low platelet count
* Liver function tests (LFTs) \> 2x normal
* Currently on a Depakote formulation or prior unsuccessful trial of Depakote
* Currently on lamotrigine (Lamictal)
* Not currently on but intends to initiate treatment with an acetylcholinesterase inhibitor or memantine during the course of the study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
60 Years
Study:
NCT00197834
Study Brief:
Protocol Section:
NCT00197834