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

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.

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

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