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

Phase 1

Completed

• Conditions: Alzheimer's Disease
• Interventions: Drug: Placebo; Drug: ITI-007

• Registration Number: NCT02078310
• Lead Sponsor: Intra-Cellular Therapies, Inc.

Brief 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

Detailed Description

Not available

Study Timeline

• Study Start: 2014-02
• Study First Submitted: 2014-02-28
• Study First Submitted QC: 2014-03-04
• Study First Posted: 2014-03-05
• Primary Completion: 2014-08
• Status Verified: 2014-11
• Study Completion: 2014-11
• Disposition First Submitted: 2017-11-08
• Disposition First Submitted QC: 2017-11-08
• Last Update Submitted: 2017-11-13
• Disposition First Posted: 2017-11-14
• Last Update Posted: 2017-11-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo Part 1	Placebo	Part 1: Healthy geriatric volunteers with placebo given
Placebo Part 2	Placebo	Part 2: Geriatric patients with dementia with placebo given
ITI-007 Part 1	ITI-007	Part 1: Healthy geriatric volunteers with multiple oral dose escalation up to and including 20 mg ITI-007
ITI-007 Part 2	ITI-007	Part 2: Geriatric patients with dementia with ITI-007 given

Primary Outcome Measures

Name	Time	Method
Number of participants with adverse events	up to 7 days	Vital signs, 12-lead ECGs, clinical laboratory testing, and adverse events will be assessed.

Secondary Outcome Measures

Name	Time	Method
Area under the concentration-time curve (AUC)	pre-dose and multiple collection points up to 72 h after the last dose