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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, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (96% lower). 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.
Primary Outcome
The MWT measures the subject's ability to stay awake while sitting quietly in a chair. The test has 4 parts, each lasting 40 minutes if the subject is able to remain awake that long each time, and the parts are spaced apart in 2 hour intervals through the day. The subject is placed in a dim room, with the only source of light slightly behind the subject's head and out of his/her field of vision, and back and neck supported. During this time the subject is monitored with the same measures that a
Interventions
- DRUG Armodafinil
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2009-11 |
| Est. Completion | 2012-03 |
| Phase | Phase 4 |
What the finished NCT01023672 record still lists
NCT01023672 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (96% lower).
The record links to 0 conditions, and to 1 intervention - of which Armodafinil is the first listed.
NCT01023672 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01023672's enrollment target sits among peer trials
20 1753rd of 2000 higher than 167 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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