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NCT02078310 · ClinicalTrials.gov registry record · Phase 1
Study of ITI-007 in Healthy Geriatric Volunteers and in Geriatric Patients With Dementia
A Phase 1 study of Alzheimers Disease, sponsored by Intra-Cellular Therapies.
- Completed
- Registry status
- Phase 1
- Development phase
- 35
- Enrollment target
- 1
- Study location
NCT02078310: Completed Phase 1 study of Alzheimers Disease, sponsored by Intra-Cellular Therapies.
NCT02078310 is a Phase 1 study of Alzheimers Disease that has completed, run by Intra-Cellular Therapies. The registered enrollment target is 35 participants, below the 3,926-participant average among 147 other Alzheimers Disease trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02078310, a Phase 1 study of Alzheimers Disease, has completed, sponsored by Intra-Cellular Therapies.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 35 participants
- Enrollment target
- 1
- Study location
Study 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
Primary Outcome
Vital signs, 12-lead ECGs, clinical laboratory testing, and adverse events will be assessed.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG ITI-007
Study Locations (1)
California
- - Glendale
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 35 participants |
| Start Date | 2014-02 |
| Est. Completion | 2014-11 |
| Phase | Phase 1 |
What the finished NCT02078310 record still lists
NCT02078310 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 35 participants, a relatively small participant target, below the 3,926-participant average among 147 other Alzheimers Disease trials with a reported enrollment target (99% lower).
The record links to 1 condition, with Alzheimers Disease appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT02078310 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT02078310 about?
NCT02078310 is a clinical study titled "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
What is the current status of trial NCT02078310?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 35 participants. The study started on 2014-02. Estimated completion is 2014-11.
What conditions does trial NCT02078310 study?
This clinical trial studies the following conditions: Alzheimers Disease.
What interventions are being tested in trial NCT02078310?
The interventions under investigation include: Placebo (DRUG), ITI-007 (DRUG).
Who is sponsoring clinical trial NCT02078310?
This trial is sponsored by Intra-Cellular Therapies, which has 37 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02078310 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Alzheimers Disease
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02078310's enrollment target sits among peer trials
35 114th of 147 higher than 33 of 147 other Alzheimers Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Alzheimers Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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