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Find more clinical trials

ITI-007 in Individuals with Dementia and Healthy Volunteers

Start: February 2014
End: November 2014
Enrollment: 52

What Is This Study About?

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.

Do I Qualify To Participate in This Study?

Minimum Age: 65 Years

Maximum Age: N/A

Must have:

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

Must NOT have:

  • 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

If I Qualify, Who Do I Contact?

Contact study personnel listed either under the general study contact or the location nearest you.

Need Help?

Contact NIA’s Alzheimer’s and related Dementias Education and Referral (ADEAR) Center at 800-438-4380 or email ADEAR.

Where Is This Study Located?

Who Sponsors This Study?

Lead: Intra-Cellular Therapies, Inc.

Source: ClinicalTrials.gov ID: NCT02078310

alzheimers.gov

An official website of the U.S. government, managed by the National Institute on Aging at the National Institutes of Health