Trial Outcomes & Findings for "Pilot Study of Armodafinil in Patients With Dementia With Lewy Bodies" (NCT NCT01023672)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

20 participants

Primary outcome timeframe

baseline, 12 weeks

Results posted on

2013-09-05

Participant Flow

Subjects were enrolled at the Mayo Clinic in Rochester, Minnesota

Participant milestones

Participant milestones
Measure	Armodifinil 150-250 mg armodafinil by mouth daily
Overall Study STARTED	20
Overall Study COMPLETED	17
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Armodifinil 150-250 mg armodafinil by mouth daily
Overall Study Worsening disease	2
Overall Study Death	1

Baseline Characteristics

"Pilot Study of Armodafinil in Patients With Dementia With Lewy Bodies"

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Armodifinil n=20 Participants 150-250 mg armodafinil by mouth daily
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=5 Participants
Age, Categorical >=65 years	19 Participants n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants
Sex: Female, Male Male	16 Participants n=5 Participants
Region of Enrollment United States	20 participants n=5 Participants

PRIMARY outcome

Timeframe: baseline, 12 weeks

Population: Per Protocol; 3 subjects did not complete the study (2 had worsening disease, and 1 died) and did not complete this test.

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.

Outcome measures

Outcome measures
Measure	Armodifinil n=17 Participants 150-250 mg armodafinil by mouth daily
Mean Initial Sleep Latency as Measured by the Maintenance of Wakefulness Test (MWT) Baseline	7.0 minutes Interval 4.25 to 19.07
Mean Initial Sleep Latency as Measured by the Maintenance of Wakefulness Test (MWT) 12 Weeks	19.0 minutes Interval 7.19 to 32.76

Adverse Events

Armodifinil

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Armodifinil n=20 participants at risk 150-250 mg armodafinil by mouth daily
Psychiatric disorders Anxiety	5.0% 1/20 • Number of events 2 • Subjects were followed for adverse events from the initiation of any study procedure until 30 days following the last administration of study treatment.
Eye disorders Blepharitis	5.0% 1/20 • Number of events 1 • Subjects were followed for adverse events from the initiation of any study procedure until 30 days following the last administration of study treatment.
Nervous system disorders Headache	5.0% 1/20 • Number of events 1 • Subjects were followed for adverse events from the initiation of any study procedure until 30 days following the last administration of study treatment.
Cardiac disorders ECG changes/prolonged QTc interval	5.0% 1/20 • Number of events 1 • Subjects were followed for adverse events from the initiation of any study procedure until 30 days following the last administration of study treatment.
Psychiatric disorders Depression	5.0% 1/20 • Number of events 1 • Subjects were followed for adverse events from the initiation of any study procedure until 30 days following the last administration of study treatment.
Ear and labyrinth disorders Otalgia	5.0% 1/20 • Number of events 1 • Subjects were followed for adverse events from the initiation of any study procedure until 30 days following the last administration of study treatment.

Additional Information

Dr. Bradley F. Boeve

Mayo Clinic

Phone: 507-266-4106

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place