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

Alzheimer's Disease Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02078310
• Other study ID #: ITI-007-200
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: February 28, 2014
• Last updated: November 13, 2017
• Start date: February 2014
• Est. completion date: November 2014

Study information

• Verified date: November 2014
• Source: Intra-Cellular Therapies, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: November 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease
• Dementia

Intervention

Drug:
• ITI-007
ITI-007 for Part 1
• Placebo
ITI-007 for Part 1
• ITI-007
ITI-007 for Part 2
• Placebo
Placebo for Part 2

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Intra-Cellular Therapies, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Exploratory measures of cognitive function		Baseline and up to 7 days
Other	Exploratory measures of agitation		Baseline and up to 7 days
Other	Exploratory measures of subjective sleep		Baseline and up to 7 days
Primary	Number of participants with adverse events	Vital signs, 12-lead ECGs, clinical laboratory testing, and adverse events will be assessed.	up to 7 days
Secondary	Area under the concentration-time curve (AUC)		pre-dose and multiple collection points up to 72 h after the last dose