Alzheimer's Disease Education and Referral Center

ITI-007 in Individuals with Dementia and Healthy Volunteers

ITI-007 in Individuals with Dementia and Healthy Volunteers

Overall Status: 
Brief Description: 

This Phase IB/II clinical trial will test the safety and efficacy of the experimental drug ITI-007 in older adults with dementia and in cognitively normal volunteers age 65 and older.

Patient Qualifications: 
Min AgeMax AgeGenderHealthy Volunteers
65 Years
Accepts Healthy Volunteers
Inclusion Criteria: 

    Healthy Participants

    • MMSE score of 26 or higher at screening
    • Body Mass Index (BMI) of 19-40 kg/m2; minimum body weight of 110 pounds at screening

    Participants with Dementia

    • Clinical diagnosis of dementia
    • MMSE score of less than 26 at screening
    • BMI of 19-40 kg/m2; minimum body weight of 110 pounds at screening
Exclusion Criteria: 
    • Clinically significant illness within the past 6 months
    • History of cancer within the last 5 years
    • History of hepatitis B or C infection and elevated ALT, AST, or bilirubin level above the upper limit of normal
    • In imminent danger to self or others
Detailed Description: 

This study will test the effects of an experimental drug, ITI-007, compared to a placebo in both cognitively normal older adults and those with dementia. Vital signs, ECG and clinical laboratory test results, and any adverse events will be assessed. ITI-007 targets multiple brain systems, including modulation of dopamine receptors and serotonin transporters. It is being tested as an alternative to existing antipsychotic drugs to treat dementia-related agitation, aggression, and sleep problems as well as schizophrenia and other psychiatric diseases.

Map Marker CityStateZip CodeStatusPrimary Contact

Geolocation is 34.1425078, -118.255075

Lead Sponsor: 
Intra-Cellular Therapies, Inc.
Collaborator Sponsor: 
Facility Investigators: 
Study Contact: 
Kimberly Vanover, PhD
Locations ID 
NCT02078310 (follow link to view full record on in new window)
Official Title: 
A Randomized, Double-blind, Placebo-controlled, Multiple Oral Dose Escalation for Safety, Tolerability and Pharmacokinetics of ITI-007 in Healthy Geriatric Volunteers and in Geriatric Patients With Dementia.
Study Start Date: 
February 2014
Study End Date: 
December 2014
Disease Stage: