Study of Depakote for Behavioral and Psychological Symptoms in Dementia

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

This prospective, naturalistic, open label study will test the hypothesis that Depakote is correlated with a reduction in elevated Cohen-Mansfield Agitation Index (CMAI) verbal and physical agitation and aggression scales over a 6-week period among patients with elevated scores on those scales, and that these positive results can be achieved with fewer side effects than with other agents. In addition, patients will be rated with respect to changes in the Clinical Global Impression (CGI) at baseline, week 1, 3, and 6 and the Neuropsychiatric Inventory (NPI) at baseline and week 6.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hearthstone Alzheimer Care
• Collaborator: Abbott
• Treatments: Antipsychotic Agents; Valproic Acid

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.