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NCT01845636 · ClinicalTrials.gov registry record · Phase 4
Olfactory Deficits in MCI as Predictor of Improved Cognition on Donepezil
A Phase 4 study, sponsored by New York State Psychiatric Institute.
- Completed
- Registry status
- Phase 4
- Development phase
- 41
- Enrollment target
NCT01845636 is a Phase 4 study that has completed, run by New York State Psychiatric Institute. The registered enrollment target is 41 participants.
The verdict
NCT01845636, a Phase 4 study, has completed, sponsored by New York State Psychiatric Institute.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 41 participants
- Enrollment target
Study Summary
Odor identification deficits, which are a result of early Alzheimer's Disease (AD) pathology in the olfactory bulb and tract as well as olfactory projection areas in the medial temporal lobe (entorhinal and piriform cortex and hippocampus), lateral and central orbitofrontal cortex and several other regions, occur in AD and strongly predict mild cognitive impairment (MCI) conversion to AD. Our pilot data, along with converging findings in the literature, suggests that odor identification deficits, both incremental change over time and change in response to an anticholinergic challenge, may be clinically simple, relatively inexpensive, predictors of cognitive improvement with acetylcholinesterase inhibitor (ACheI) treatment with potential clinical implications for predicting improvement and monitoring ACheI therapy.
Interventions
- DRUG Atropine
- DRUG Donepezil
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 41 participants |
| Start Date | 2012-08 |
| Est. Completion | 2016-03 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01845636
The ClinicalTrials.gov registry entry for NCT01845636 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 41 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is New York State Psychiatric Institute, which has 364 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Atropine is the first listed.
NCT01845636 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01845636 about?
NCT01845636 is a clinical study titled "Olfactory Deficits in MCI as Predictor of Improved Cognition on Donepezil". Odor identification deficits, which are a result of early Alzheimer's Disease (AD) pathology in the olfactory bulb and tract as well as olfactory projection areas in the medial temporal lobe (entorhinal and piriform cortex and hippocampus), lateral and central orbitofrontal cortex and several other ...
What is the current status of trial NCT01845636?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 41 participants. The study started on 2012-08. Estimated completion is 2016-03.
What interventions are being tested in trial NCT01845636?
The interventions under investigation include: Atropine (DRUG), Donepezil (DRUG).
Who is sponsoring clinical trial NCT01845636?
This trial is sponsored by New York State Psychiatric Institute, which has 364 total clinical trials registered on ClinicalTrials.gov.
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