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

Study Overview
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Brief Summary
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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

Official Title
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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.

Conditions
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Alzheimer's Disease

Intervention / Treatment
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* Drug: ITI-007
* Drug: Placebo
* Drug: ITI-007
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ITI-007 Part 1<br>Part 1: Healthy geriatric volunteers with multiple oral dose escalation up to and including 20 mg ITI-007 | Drug: ITI-007<br>* ITI-007 for Part 1<br>|
| Placebo Comparator: Placebo Part 1<br>Part 1: Healthy geriatric volunteers with placebo given | Drug: Placebo<br>* ITI-007 for Part 1<br>|
| Experimental: ITI-007 Part 2<br>Part 2: Geriatric patients with dementia with ITI-007 given | Drug: ITI-007<br>* ITI-007 for Part 2<br>|
| Placebo Comparator: Placebo Part 2<br>Part 2: Geriatric patients with dementia with placebo given | Drug: Placebo<br>* Placebo for Part 2<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dementia,, Healthy, geriatric, volunteers, patients