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OpenTrials
Completed

NCT Number: NCT02078310

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

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

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Key information

Conditions

Alzheimer's Disease Alzheimer Disease Brain Diseases Central Nervous System Diseases Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Glendale, California, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ITI-007

Drug

ITI-007 for Part 1

Placebo

Drug

ITI-007 for Part 1

Primary outcomes

  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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Intra-Cellular Therapies, Inc.

Industry

Registry information

Official study 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.

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Mar 5, 2014
Registry last updated
Nov 17, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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