The purpose of the current study is to assess the efficacy, safety, and tolerability of ITI-1284 for the treatment of agitation associated with Alzheimer’s dementia. Patients will be monitored carefully for their mental health status and general health. Symptoms of agitation may or may not improve during participation in the study; approximately half of the patients in this study will receive placebo. However, the information obtained from this study may help to develop treatment for people with AD experiencing agitation in the future.
ITI-1284-101
A Multicenter, Randomized, Double-blind, Placebo-controlled, Flexible-dose Study of the Efficacy, Safety, and Tolerability of ITI-1284 in Patients with Agitation Associated with Alzheimer's Dementia
Alzheimer's disease
All genders
55+
Recruiting now
Overview
Principal Investigator: Brent P. Forester, MD MSc
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Claudia Marmelo
Study details
Inclusion Criteria
- Onset of symptoms of agitation at least 2 weeks prior to screening
- Meets clinical criteria for Alzheimer's disease
- MMSE score between 6 and 24
Exclusion Criteria
- Agitation that is attributable to concomitant medications, adverse environmental conditions, substance abuse, or active medical or psychiatry conditions.
- Diagnosis of: Schizophrenia, Schizoaffective Disorder or other Psychotic Disorder, Bipolar Disorder, or Major Depressive Disorder.
Study Requirements
This is a twelve long trial where participants with 10 in person visits and 5 follow-up phone calls. Participants will complete an ECG, blood draws, questionnaires, and will receive either placebo or study drug.