Dementia With Lewy BodiesPhase 4NCT01023672
"Pilot Study of Armodafinil in Patients With Dementia With Lewy Bodies"
A Phase 4 study testing Armodafinil in people with Dementia With Lewy Bodies, run by Mayo Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 90 years
- Conditions the study is for
- Dementia With Lewy Bodies
- What is being tested?
- Armodafinil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2009to Mar 2012
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of clinically possible or probable DLB using established criteria
- Age 50-90 inclusive
- Epworth Sleepiness Scale score of 8 or greater
- MMSE score between 10 and 26 inclusive
- No active medical disorder that could preclude participation in a drug treatment trial over a 12 week protocol
- Stable medication regimen over previous four weeks
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- Absence of psychotropic medications at doses viewed by the clinician to be significantly impacting the patient's alertness during wakefulness
- Absence of clinically significant primary sleep-related breathing disorder causing sleepiness as demonstrated by polysomnography (PSG) [ie, no significant upper airway resistance syndrome (UARS), obstructive sleep apnea (OSA), nor central sleep apnea (CSA) as reflected by a combined respiratory disturbance index (RDI) <15] OR adequate documentation of efficacy of treatment for UARS, OSA, and CSA
- Caregiver that is with the patient at least 4 hours/day for at least 5 days per week
- Patient and caregiver willing and able to participate in all study-related procedures
- Patient is capable of giving informed consent, or if appropriate, has caregiver capable of giving consent on the subject's behalf.
Who cannot join
- Does not fulfill criteria for clinically possible or probable DLB
- Age <50 or >90
- Women with intact uterus and not post-menopausal unless pregnancy test performed at screening is negative
- Epworth Sleepiness Scale score less than 8
- MMSE score <10 or >26
- Active medical disorder that could preclude participation in a drug treatment trial over a 52 week protocol, such as:
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- Hypertension with BP readings exceeding 150 mm Hg systolic and 90 mm Hg diastolic
- Hypersensitivity to modafinil, armodafinil, or any other conventional stimulants
- Myocardial infarction or cerebral infarct over preceding year, stable or unstable angina, known symptomatic coronary artery disease
- History of left ventricular hypertrophy or mitral valve prolapse
- History of chronic or paroxysmal atrial fibrillation, chronic or paroxysmal atrial flutter, ventricular fibrillation, or ventricular tachycardia
- History of cancer over preceding 1 year (excluding squamous or basal cell carcinoma of the skin)
- History of Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and drug rash with eosinophilia and systemic symptoms (DRESS)
- Pulmonary disease requiring oral or inhalatory medications
- Any other medical disorder considered by the study physicians as inappropriate for any wake-promoting medication
- Medication regimen has not been stable over preceding four weeks
- Concurrent use of lamotrigine or oxcarbazepine
- Presence of over-the-counter and prescription psychotropic medications at doses viewed by the clinician to be significantly impacting the patient's alertness during wakefulness, such as:
- Clonazepam > 1 mg/night
- Seroquel > 100 mg/night
- Zyprexa > 10 mg/night
- Presence of another clinically-significant primary sleep disorder (eg, UARS, OSA, CSA) that is not being treated
- Clinically significant abnormalities on screening ECG or laboratory tests
- Patient or caregiver unwilling or unable to participate in all study-related procedures
- Caregiver is not with patient at least 4 hours/day for at least 5 days/week
- Patient or caregiver unwilling or unable to provide informed consent
- CT or MRI evidence of a clinically significant structural lesion that could account for the participants dementia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open Label, Single-Center 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.
Read more
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.
Read the detailed description
In patients with DLB, the following aims/objectives will be addressed by comparing data on key measures at baseline and at 4 and 12 weeks of therapy:
Primary Aims - to test the hypotheses that armodafinil therapy at 150-250 mg every morning:
- will result in improvement in excessive daytime sleepiness as measured by the Epworth Sleepiness Scale (ESS) and Maintenance of Wakefulness Test (MWT) (Aim 1A)
- will result in improvement in the cognitive subscale of the Alzheimer's Disease Assessment Scale (ADAS-Cog) (Aim 1B)
- will result in improvement in the Alzheimer's Disease Cooperative Study-Clinician's Global Impression of Change (ADCS-CGIC) (Aim 1C)
- will be well-tolerated with no significant side-effects present (Aim 1D)
Secondary Aims - to test the hypotheses that armodafinil therapy at 150-250 mg every morning will result in improvement in:
- cognition as measured by the Mini-Mental State Examination (MMSE) and other focused neuropsychological tests (Aim 2A)
- neuropsychiatric morbidity, particularly apathy, depression, visual hallucinations, and delusions, as measured by the Neuropsychiatric Inventory (NPI) (Aim 2B)
- functional status as measured by the Alzheimer's Disease Cooperative Study-Activities of Daily Living (ADCS-ADL) (Aim 2C)
- patient and caregiver quality of life (QOL) as measured by the linear analog scale (LASA) (Aim 2D)
- Conditions
- Dementia With Lewy Bodies
- Being tested
- Armodafinil
- Keywords
- Dementia with Lewy Bodies, hypersomnolence, cognition, neuropsychiatric morbidity, quality of life
- Medical subject headings
- Lewy Body Disease, Disorders of Excessive Somnolence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ArmodafinilDrug
Also called Nuvigil
150-250 mg armodafinil by mouth daily
| Study group | Role | What they receive |
|---|---|---|
| Armodifinil | Other | 150-250 mg armodafinil by mouth daily Receives: Drug: Armodafinil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Initial Sleep Latency as Measured by the Maintenance of Wakefulness Test (MWT)
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 are used in a standard overnight sleep study called a polysomnogram. The sleep latency, or time it takes the subject to fall asleep, will be recorded.
In healthy people, the time it takes to fall asleep may be approximately 30 minutes on the test. More than 97% of people will take eight minutes or longer to fall asleep. Therefore, sleep latency that is less than eight minutes is considered to be abnormal.
Measured: baseline, 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2009 (estimated)
- Study startNov 2009
- Primary completionMar 2012
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Dementia With Lewy BodiesStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Cephalon, National Institute on Aging (NIA)
- Investigators
- Bradley F Boeve, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01023672
- Sponsor's protocol ID
- 09-003438
- Other IDs
- R01AG015866, P50AG016574
- Status last verified
- Jun 2013
- First submitted
- 1 Dec 2009
- Last updated
- 5 Sep 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Single-Center Pilot Study of Armodafinil in Patients With Dementia With Lewy Bodies
- ClinicalTrials.gov ID
- NCT01023672
- Acronym / sponsor ID
- 09-003438
- Conditions
- Dementia With Lewy Bodies
- Keywords
- Dementia with Lewy Bodies, hypersomnolence, cognition, neuropsychiatric morbidity, quality of life
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- Cephalon, National Institute on Aging (NIA)
- Study start
- Nov 2009
- Primary completion
- Mar 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 2 Dec 2009 (estimated)
- Results
- Posted 5 Sep 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
In patients with DLB, the following aims/objectives will be addressed by comparing data on key measures at baseline and at 4 and 12 weeks of therapy:
Primary Aims - to test the hypotheses that armodafinil therapy at 150-250 mg every morning:
- will result in improvement in excessive daytime sleepiness as measured by the Epworth Sleepiness Scale (ESS) and Maintenance of Wakefulness Test (MWT) (Aim 1A)
- will result in improvement in the cognitive subscale of the Alzheimer's Disease Assessment Scale (ADAS-Cog) (Aim 1B)
- will result in improvement in the Alzheimer's Disease Cooperative Study-Clinician's Global Impression of Change (ADCS-CGIC) (Aim 1C)
- will be well-tolerated with no significant side-effects present (Aim 1D)
Secondary Aims - to test the hypotheses that armodafinil therapy at 150-250 mg every morning will result in improvement in:
- cognition as measured by the Mini-Mental State Examination (MMSE) and other focused neuropsychological tests (Aim 2A)
- neuropsychiatric morbidity, particularly apathy, depression, visual hallucinations, and delusions, as measured by the Neuropsychiatric Inventory (NPI) (Aim 2B)
- functional status as measured by the Alzheimer's Disease Cooperative Study-Activities of Daily Living (ADCS-ADL) (Aim 2C)
- patient and caregiver quality of life (QOL) as measured by the linear analog scale (LASA) (Aim 2D)
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Armodifinil | Other | Drug: Armodafinil150-250 mg armodafinil by mouth daily |
Who may qualify
- Ages
- 50 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Diagnosis of clinically possible or probable DLB using established criteria
- Age 50-90 inclusive
- Epworth Sleepiness Scale score of 8 or greater
- MMSE score between 10 and 26 inclusive
- No active medical disorder that could preclude participation in a drug treatment trial over a 12 week protocol
Key exclusion criteria (27 listed)
- Does not fulfill criteria for clinically possible or probable DLB
- Age <50 or >90
- Women with intact uterus and not post-menopausal unless pregnancy test performed at screening is negative
- Epworth Sleepiness Scale score less than 8
- MMSE score <10 or >26
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ArmodafinilAlso: Nuvigil150-250 mg armodafinil by mouth daily | Drug | Armodifinil |
Primary outcome
Mean Initial Sleep Latency as Measured by the Maintenance of Wakefulness Test (MWT)
Time frame: baseline, 12 weeks
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 are used in a standard overnight sleep study called a polysomnogram. The sleep latency, or time it takes the subject to fall asleep, will be recorded. In healthy people, the time it takes to fall asleep may be approximately 30 minutes on the test. More than 97% of people will take eight minutes or longer to fall asleep. Therefore, sleep latency that is less than eight minutes is considered to be abnormal.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bradley F Boeve, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Armodafinil in people with Dementia With Lewy Bodies, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Sep 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Initial Sleep Latency as Measured by the Maintenance of Wakefulness Test (MWT) (time frame: baseline, 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2013.