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

Intra-Cellular Therapies

Status and phase: Completed; Phase 2; Phase 1

Conditions: Alzheimer's Disease

Treatments: Drug: Placebo; Drug: ITI-007

Study type: Interventional

Funder types: Industry

Identifiers

NCT02078310

ITI-007-200

Details and patient eligibility

About

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

Enrollment: 35 patients

Sex: All

Ages: 65+ years old

Volunteers: Accepts 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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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35 participants in 4 patient groups, including a placebo group

ITI-007 Part 1

Experimental group

Description:

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

Treatment:

Drug: ITI-007

Drug: ITI-007

Placebo Part 1

Placebo Comparator group

Description:

Part 1: Healthy geriatric volunteers with placebo given

Treatment:

Drug: Placebo

Drug: Placebo

ITI-007 Part 2

Experimental group

Description:

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

Treatment:

Drug: ITI-007

Drug: ITI-007

Placebo Part 2

Placebo Comparator group

Description:

Part 2: Geriatric patients with dementia with placebo given

Treatment:

Drug: Placebo

Drug: Placebo