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NCT01951118 · ClinicalTrials.gov registry record · Phase 4
Olfactory Deficits and Donepezil Treatment in Cognitively Impaired Elderly
A Phase 4 study, sponsored by New York State Psychiatric Institute.
- Completed
- Registry status
- Phase 4
- Development phase
- 121
- Enrollment target
NCT01951118 is a Phase 4 study that has completed, run by New York State Psychiatric Institute. The registered enrollment target is 121 participants.
The verdict
NCT01951118, a Phase 4 study, has completed, sponsored by New York State Psychiatric Institute.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 121 participants
- Enrollment target
Study Summary
Olfactory identification deficits occur in patients with Alzheimer's disease (AD), are associated with disease severity, predict conversion from mild cognitive impairment (MCI) to AD and are associated with healthy elderly subjects developing MCI. Odor (olfactory) identification deficits may reflect degeneration of cholinergic inputs to the olfactory bulb and other olfactory brain regions. Acetylcholinesterase inhibitors (ACheI) like donepezil show modest effects in improving cognition but can be associated with adverse effects and increased burden and costs because of the need for prolonged, often lifelong, treatment. Converging findings on odor identification test performance (UPSIT, scratch and sniff 40-item test) from four pilot studies, including two of our own, suggest that acute change in the UPSIT in response to an anticholinergic challenge (atropine nasal spray), incremental change over 8 weeks, and even the baseline UPSIT score by itself, may predict cognitive improvement with ACheI treatment in MCI and AD. If change in odor identification deficits can help to identify which patients should receive ACheI treatment, this simple inexpensive approach will advance the goal of improving personalized treatment, improve selection and monitoring of patients for ACheI treatment, reduce needless ACheI exposure with risk of side effects, and decrease health care costs.
Interventions
- DRUG Donepezil
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 121 participants |
| Start Date | 2013-10 |
| Est. Completion | 2019-05 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01951118
The ClinicalTrials.gov registry entry for NCT01951118 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 121 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 1 intervention - of which Donepezil is the first listed.
NCT01951118 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01951118 about?
NCT01951118 is a clinical study titled "Olfactory Deficits and Donepezil Treatment in Cognitively Impaired Elderly". Olfactory identification deficits occur in patients with Alzheimer's disease (AD), are associated with disease severity, predict conversion from mild cognitive impairment (MCI) to AD and are associated with healthy elderly subjects developing MCI. Odor (olfactory) identification deficits may reflect...
What is the current status of trial NCT01951118?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 121 participants. The study started on 2013-10. Estimated completion is 2019-05.
What interventions are being tested in trial NCT01951118?
The interventions under investigation include: Donepezil (DRUG).
Who is sponsoring clinical trial NCT01951118?
This trial is sponsored by New York State Psychiatric Institute, which has 364 total clinical trials registered on ClinicalTrials.gov.
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