Alzheimer Disease, Insomnia, Sleep Initiation and Maintenance Disorders
Conditions
Keywords
Mild Cognitive Impairment (MCI), Sleep, Fatigue, Memory
Brief summary
Modafinil, trade named Provigil, is a medication approved by the Food and Drug Administration for the treatment of narcolepsy, obstructive sleep apnea/hypopnea syndrome, and shift work sleep disorder. Each of these problems is characterized by difficulty sleeping at night and excessive daytime sleepiness. Modafinil is prescribed during the day to counteract this sleepiness. The idea behind this treatment is that sleepiness that leads to napping during the day prevents a patient from being tired or sleepy enough to get good sleep at night. This study is designed to determine if the medication can reset participants' sleep/wake rhythm to a more normal rhythm.
Interventions
DRUGmodafinil
100-400 mg daily for 4 weeks
Sponsors
VA Palo Alto Health Care System
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* A clinical diagnosis of Alzheimer's disease or Mild Cognitive Impairment * Subjective complaint of sleep disruption, unsatisfactory sleep, early morning awakening, early bedtime, or excessive daytime sleepiness. Such complaint can be made by either the potential participant or by the caregiver.
Exclusion criteria
* Participation in any other clinical drug trial * Liver failure * Believed by the investigator to be unwilling or unable to follow the protocol * Active liver or coronary disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Nocturnal Sleep Length at 1 Month | 1 month |
Secondary
| Measure | Time frame |
|---|---|
| Improvement of Daytime Alertness and Quality of Life. | ~1 month |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Modafinil Open label study in which all participants get modafinil | 2 |
| Total | 2 |
Baseline characteristics
| Characteristic | Modafinil |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 2 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants |
| Region of Enrollment United States | 2 participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 2 |
| other Total, other adverse events | 0 / 2 |
| serious Total, serious adverse events | 0 / 2 |
Outcome results
Primary
Nocturnal Sleep Length at 1 Month
Time frame: 1 month
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Modafinil | Nocturnal Sleep Length at 1 Month | 9.5 hours |
Secondary
Improvement of Daytime Alertness and Quality of Life.
Time frame: ~1 month