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NCT01023672 · ClinicalTrials.gov registry record · Phase 4
"Pilot Study of Armodafinil in Patients With Dementia With Lewy Bodies"
A Phase 4 study, sponsored by Mayo Clinic.
- Completed
- Registry status
- Phase 4
- Development phase
- 20
- Enrollment target
NCT01023672: Completed Phase 4 study, sponsored by Mayo Clinic.
NCT01023672 is a Phase 4 study that has completed, run by Mayo Clinic. The registered enrollment target is 20 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01023672, a Phase 4 study, has completed, sponsored by Mayo Clinic.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 20 participants
- Enrollment target
Study Summary
This research study is to examine the effects of the study medication Armodafinil in patients with dementia with Lewy bodies (DLB). DLB is associated with memory and other thinking problems, excessive daytime sleepiness, hallucinations, delusions, apathy, and reduced quality of life. One type of medication that could potentially improve daytime sleepiness, memory and thinking skills, hallucinations, delusions, apathy, and quality of life is known as a wake-promoting medication. Armodafinil is a wake-promoting medication that has been developed for treatment of patients with narcolepsy, sleep apnea, and other disorders which cause excessive daytime sleepiness. The drug used in this study is considered investigational, which means it has either not been approved by the Food and Drug Administration (FDA) for routine clinical use or for the use described in this study. However the FDA has allowed the use of this drug/device in this research study. In this study, patients with DLB will receive daily oral Armodafinil tablets, and their response to treatment will be assessed over 12 weeks. This study does not involve any placebo medication, so all patients will receive Armodafinil treatment.
Interventions
- DRUG Armodafinil
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2009-11 |
| Est. Completion | 2012-03 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01023672
The ClinicalTrials.gov registry entry for NCT01023672 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Mayo Clinic, which has 2,844 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Armodafinil is the first listed.
NCT01023672 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01023672 about?
NCT01023672 is a clinical study titled ""Pilot Study of Armodafinil in Patients With Dementia With Lewy Bodies"". This research study is to examine the effects of the study medication Armodafinil in patients with dementia with Lewy bodies (DLB). DLB is associated with memory and other thinking problems, excessive daytime sleepiness, hallucinations, delusions, apathy, and reduced quality of life. One type of m...
What is the current status of trial NCT01023672?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 20 participants. The study started on 2009-11. Estimated completion is 2012-03.
What interventions are being tested in trial NCT01023672?
The interventions under investigation include: Armodafinil (DRUG).
Who is sponsoring clinical trial NCT01023672?
This trial is sponsored by Mayo Clinic, which has 2,844 total clinical trials registered on ClinicalTrials.gov.
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