MedDataX Logo

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

NCT ID: NCT02078310

Last Updated: 2017-11-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-02-28

Study Completion Date

2014-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Alzheimer's Disease

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Dementia, Healthy geriatric volunteers patients

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

ITI-007 Part 1

Part 1: Healthy geriatric volunteers with multiple oral dose escalation up to and including 20 mg ITI-007

Group Type EXPERIMENTAL

ITI-007

Intervention Type DRUG

ITI-007 for Part 1

Placebo Part 1

Part 1: Healthy geriatric volunteers with placebo given

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

ITI-007 for Part 1

ITI-007 Part 2

Part 2: Geriatric patients with dementia with ITI-007 given

Group Type EXPERIMENTAL

ITI-007

Intervention Type DRUG

ITI-007 for Part 2

Placebo Part 2

Part 2: Geriatric patients with dementia with placebo given

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo for Part 2

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

ITI-007

ITI-007 for Part 1

Intervention Type DRUG

Placebo

ITI-007 for Part 1

Intervention Type DRUG

ITI-007

ITI-007 for Part 2

Intervention Type DRUG

Placebo

Placebo for Part 2

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Intra-Cellular Therapies, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Glendale, California, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

ITI-007-200

Identifier Type: -

Identifier Source: org_study_id