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

Primary Purpose

Alzheimer's Disease

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
ITI-007
Placebo
ITI-007
Placebo
Sponsored by
Intra-Cellular Therapies, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Alzheimer's Disease focused on measuring Dementia,, Healthy, geriatric, volunteers, patients

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Arm Label

ITI-007 Part 1

Placebo Part 1

ITI-007 Part 2

Placebo Part 2

Arm Description

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

Part 1: Healthy geriatric volunteers with placebo given

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

Part 2: Geriatric patients with dementia with placebo given

Outcomes

Primary Outcome Measures

Number of participants with adverse events
Vital signs, 12-lead ECGs, clinical laboratory testing, and adverse events will be assessed.

Secondary Outcome Measures

Area under the concentration-time curve (AUC)

Full Information

First Posted
February 28, 2014
Last Updated
November 13, 2017
Sponsor
Intra-Cellular Therapies, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02078310
Brief Title
Study of ITI-007 in Healthy Geriatric Volunteers and in Geriatric Patients With Dementia
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 Type
Interventional

2. Study Status

Record Verification Date
November 2014
Overall Recruitment Status
Completed
Study Start Date
February 2014 (undefined)
Primary Completion Date
August 2014 (Actual)
Study Completion Date
November 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Intra-Cellular Therapies, Inc.

4. Oversight

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

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer's Disease
Keywords
Dementia,, Healthy, geriatric, volunteers, patients

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
35 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ITI-007 Part 1
Arm Type
Experimental
Arm Description
Part 1: Healthy geriatric volunteers with multiple oral dose escalation up to and including 20 mg ITI-007
Arm Title
Placebo Part 1
Arm Type
Placebo Comparator
Arm Description
Part 1: Healthy geriatric volunteers with placebo given
Arm Title
ITI-007 Part 2
Arm Type
Experimental
Arm Description
Part 2: Geriatric patients with dementia with ITI-007 given
Arm Title
Placebo Part 2
Arm Type
Placebo Comparator
Arm Description
Part 2: Geriatric patients with dementia with placebo given
Intervention Type
Drug
Intervention Name(s)
ITI-007
Intervention Description
ITI-007 for Part 1
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
ITI-007 for Part 1
Intervention Type
Drug
Intervention Name(s)
ITI-007
Intervention Description
ITI-007 for Part 2
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo for Part 2
Primary Outcome Measure Information:
Title
Number of participants with adverse events
Description
Vital signs, 12-lead ECGs, clinical laboratory testing, and adverse events will be assessed.
Time Frame
up to 7 days
Secondary Outcome Measure Information:
Title
Area under the concentration-time curve (AUC)
Time Frame
pre-dose and multiple collection points up to 72 h after the last dose
Other Pre-specified Outcome Measures:
Title
Exploratory measures of cognitive function
Time Frame
Baseline and up to 7 days
Title
Exploratory measures of agitation
Time Frame
Baseline and up to 7 days
Title
Exploratory measures of subjective sleep
Time Frame
Baseline and up to 7 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Facility Information:
City
Glendale
State/Province
California
Country
United States

12. IPD Sharing Statement

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

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