Study of ITI-007 in Healthy Geriatric Volunteers and in Geriatric Patients With Dementia
| Status: | Completed |
|---|---|
| Conditions: | Alzheimer Disease, Neurology |
| Therapuetic Areas: | Neurology |
| Healthy: | No |
| Age Range: | 65 - Any |
| Updated: | 11/19/2017 |
| Start Date: | February 2014 |
| End Date: | November 2014 |
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.
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
Study to Assess Safety, Tolerability and Pharmacokinetics of ITI-007 in Healthy Geriatric
Volunteers and in Geriatric Patients with Dementia
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
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