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

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.

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02078310

Enrollment

Registered

2014-03-05

Start date

2014-02-28

Completion date

2014-11-30

Last updated

2017-11-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alzheimer's Disease

Keywords

Dementia,, Healthy, geriatric, volunteers, patients

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

Interventions

DRUGITI-007

ITI-007 for Part 1

DRUGPlacebo

ITI-007 for Part 1

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

65 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Number of participants with adverse events	up to 7 days	Vital signs, 12-lead ECGs, clinical laboratory testing, and adverse events will be assessed.

Secondary

Measure	Time frame
Area under the concentration-time curve (AUC)	pre-dose and multiple collection points up to 72 h after the last dose

Other

Measure	Time frame
Exploratory measures of cognitive function	Baseline and up to 7 days
Exploratory measures of agitation	Baseline and up to 7 days
Exploratory measures of subjective sleep	Baseline and up to 7 days

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026