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

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ClinicalTrials.gov Identifier: NCT02078310
Recruitment Status : Completed
First Posted : March 5, 2014
Last Update Posted : November 17, 2017
Sponsor:
Information provided by (Responsible Party):
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

Condition or disease Intervention/treatment Phase
Alzheimer's Disease Drug: ITI-007 Drug: Placebo Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 35 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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.
Study Start Date : February 2014
Actual Primary Completion Date : August 2014
Actual Study Completion Date : November 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dementia
U.S. FDA Resources

Arm Intervention/treatment
Experimental: ITI-007 Part 1
Part 1: Healthy geriatric volunteers with multiple oral dose escalation up to and including 20 mg ITI-007
Drug: ITI-007
ITI-007 for Part 1
Placebo Comparator: Placebo Part 1
Part 1: Healthy geriatric volunteers with placebo given
Drug: Placebo
ITI-007 for Part 1
Experimental: ITI-007 Part 2
Part 2: Geriatric patients with dementia with ITI-007 given
Drug: ITI-007
ITI-007 for Part 2
Placebo Comparator: Placebo Part 2
Part 2: Geriatric patients with dementia with placebo given
Drug: Placebo
Placebo for Part 2



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


Secondary Outcome Measures :
  1. Area under the concentration-time curve (AUC) [ Time Frame: pre-dose and multiple collection points up to 72 h after the last dose ]

Other Outcome Measures:
  1. Exploratory measures of cognitive function [ Time Frame: Baseline and up to 7 days ]
  2. Exploratory measures of agitation [ Time Frame: Baseline and up to 7 days ]
  3. Exploratory measures of subjective sleep [ Time Frame: Baseline and up to 7 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02078310


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

Responsible Party: Intra-Cellular Therapies, Inc.
ClinicalTrials.gov Identifier: NCT02078310     History of Changes
Other Study ID Numbers: ITI-007-200
First Posted: March 5, 2014    Key Record Dates
Last Update Posted: November 17, 2017
Last Verified: November 2014

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

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