Study of ITI-007 in Healthy Geriatric Volunteers and in Geriatric Patients With Dementia

• Status: Completed
• Trial end date: 2014-11-01
• Target enrollment: 0
• Participant gender: All

Summary

A Phase 1b/2, Randomized, Double-blind, Placebo-Controlled, Multiple Oral Dose Escalation Study to Assess Safety, Tolerability and Pharmacokinetics of ITI-007 in Healthy Geriatric Volunteers and in Geriatric Patients with Dementia

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Intra-Cellular Therapies, Inc.

Criteria

Inclusion Criteria:

Part 1

• Healthy geriatric volunteers

• MMSE score of >= 26 at screening

• BMI between 19.0 and 40.0 kg/m2 and a minimum body weight of 50 kg at screening

Part 2

• Geriatric patients with a clinical diagnosis of dementia

• MMSE score of < 26 at screening

• BMI between 19.0 and 40.0 kg/m2 and a minimum body weight of 50 kg at screening

Exclusion Criteria:

• Any clinically significant illness within 6 months before screening

• Any history of cancer within last 5 years

• History of Hepatitis B or C infection and elevated ALT, AST or bilirubin above the upper limit of normal level

• Any subject considered to be an imminent danger to themselves or others