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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: Completed Phase 4 study, sponsored by New York State Psychiatric Institute.
NCT01845636 is a Phase 4 study that has completed, run by New York State Psychiatric Institute. The registered enrollment target is 41 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The Selective Reminding Test (SRT) is a 12-item test of verbal learning and memory. To administer, the researcher will read aloud a list of 12 words. The participant repeats each word aloud to ensure that the word was heard correctly. Immediately following the reading of all 12 words, the participant is asked to recall as many words as possible within the one minute time limit. The participant is then reminded of the words they did not say and asked to recall the list again. This process is repe
Interventions
- DRUG Atropine
- DRUG Donepezil
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 41 participants |
| Start Date | 2012-08 |
| Est. Completion | 2016-03 |
| Phase | Phase 4 |
What the finished NCT01845636 record still lists
NCT01845636 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 41 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (92% lower).
The record links to 0 conditions, and to 2 interventions - of which Atropine is the first listed.
NCT01845636 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01845636's enrollment target sits among peer trials
41 1390th of 2000 higher than 604 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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