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

Completed · Phase 1/Phase 2 · Has a placebo group

Conditions studied: Alzheimer's Disease

In brief

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

Key facts

Study ID

NCT02078310

Run by

Intra-Cellular Therapies, Inc.

People needed

35

Starts

2014-02-01

Expected to finish

2014-11-01

Last updated by the study team

2017-11-17

Who can join

Age: 65 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Study site — Glendale, California, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.