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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Intra-Cellular Therapies, Inc.
ClinicalTrials.gov Identifier:
NCT02078310
First received: February 28, 2014
Last updated: November 25, 2014
Last verified: November 2014
  Purpose
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

Condition Intervention Phase
Alzheimer's Disease
Drug: ITI-007
Drug: Placebo
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
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.

Resource links provided by NLM:


Further study details as provided by Intra-Cellular Therapies, Inc.:

Primary Outcome Measures:
  • Number of participants with adverse events [ Time Frame: up to 7 days ] [ Designated as safety issue: Yes ]
    Vital signs, 12-lead ECGs, clinical laboratory testing, and adverse events will be assessed.


Secondary Outcome Measures:
  • Area under the concentration-time curve (AUC) [ Time Frame: pre-dose and multiple collection points up to 72 h after the last dose ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Exploratory measures of cognitive function [ Time Frame: Baseline and up to 7 days ] [ Designated as safety issue: No ]
  • Exploratory measures of agitation [ Time Frame: Baseline and up to 7 days ] [ Designated as safety issue: No ]
  • Exploratory measures of subjective sleep [ Time Frame: Baseline and up to 7 days ] [ Designated as safety issue: No ]

Enrollment: 35
Study Start Date: February 2014
Study Completion Date: November 2014
Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ITI-007

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

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

Drug: ITI-007
Placebo Comparator: Placebo

Part 1: Healthy geriatric volunteers with placebo given

Part 2: Geriatric patients with dementia with placebo given

Drug: Placebo

  Eligibility

Ages Eligible for Study:   65 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02078310

Locations
United States, California
Glendale, California, United States
Sponsors and Collaborators
Intra-Cellular Therapies, Inc.
  More Information

Responsible Party: Intra-Cellular Therapies, Inc.
ClinicalTrials.gov Identifier: NCT02078310     History of Changes
Other Study ID Numbers: ITI-007-200 
Study First Received: February 28, 2014
Last Updated: November 25, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Intra-Cellular Therapies, Inc.:
Dementia,
Healthy
geriatric
volunteers
patients

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on September 29, 2016