Alzheimer's Disease, Insomnia, Sleep, Sleep Disorders
Conditions
Keywords
Sleep Disturbances, Alzheimer Disease, Insomnia, Z-Drugs, Treatment
Brief summary
The purpose of this study is to determine whether Zolpidem and Zoplicone are efective in the treatment of sleep disorders in Alzheimer's disease (AD)
Detailed description
Sleep disorders (SD) affects 35 to 50 percent of patients with AD. These disorders often make caring for patients at home very difficult. Zolpidem and Zoplicone are prescribed drugs for sleep disorder in AD patients.
Interventions
DRUGZolpidem
Zolpidem tablets, 10mg, 10pm (before bedtime) for 14 nights
DRUGZoplicone
Zoplicone tablets, 7.5mg, 10pm (before bedtime) for 14 nights
DRUGPlacebo
Inactive or inert pill which will be used as a comparator
Sponsors
Brasilia University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
55 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 55 years of age or older * Diagnosis of probable Alzheimer's disease (AD) by National Institute of Neurological and Communicative Disorders and Stroke / the Alzheimer's Disease and Related Disorders Association Criteria * Hachinski Ischemia Scale less than 5 * Mini-Mental State Examination score of 0 to 26 * Actigraph evidence of a mean time immobile of less than 7 hours per night based on at least 7 nights of complete actigraph data collected over a single week * Four-week history of sleep disorder behaviors, occurring at least once weekly, as reported by the caregiver using the Neuropsychiatric Inventory (NPI) Nighttime Behavior scale * Sleep disturbance observed was not present before the diagnosis of AD * Other co-morbidities, especially delirium, depression, chronic pain and medication use may be present, but do not cooperate in the primary symptoms * Computed tomography or magnetic resonance imaging since the onset of memory problems showing no more than 1 lacunar infract in a nonstrategic area and no clinical events suggestive of stroke or other intracranial disease or normal * Stable medications for 4 weeks prior to the screening visit * Having a mobile upper extremity to which to attach an actigraph * Residing with a responsible spouse, family member, or professional caregiver who is present during the night and would agree to assume the role of the principle caregiver for the 3-week protocol * Ability to ingest oral medication and participate in all scheduled evaluations
Exclusion criteria
* Sleep disturbance associated with an acute illness, delirium or psychiatric disease * Clinically significant movement disorder, such as akinesia, that would affect actigraphic differentiation of sleep and wakefulness * Severe agitation * Unstable medical condition * Discontinuation of psychotropic or sleep medication within 2 weeks of the screening visit * Patient unwilling to maintain caffeine abstinence after 2:00pm for the duration of the protocol * Patient unwilling to comply with the maximum limit of 2 alcoholic drinks per day, and only 1 alcoholic drink after 6:00pm for the duration of the protocolo * Prior use of zolpidem/zoplicone for the treatment os sleep disturbances * Caregiver deemed to be unreliable to supervise the wearing of the actigraph, to administer study capsules at the proper time, to maintain the sleep diary, or to bring the patient to the scheduled visits
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Nighttime Total Sleep Time | Baseline, 14 days follow-up | Mean Total Sleep Time (in minutes) during the 12h nocturnal period (8:00pm-8:00am) after 2 weeks under treatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Ratio of daytime to nighttime sleep | Baseline, 14 days follow-up | Daytime Total Sleep Time / Nighttime Total Sleep Time |
| Nighttime Wake after Sleep Onset | Baseline, 14 days follow-up | Nighttime Wake after Sleep Onset (in minutes) during the 12h nocturnal period (8:00pm-8:00am) after 2 weeks under treatment |
| Proportion of sleep time at nighttime | Baseline, 14 days follow-up | Proportion of sleep time (%) during the 12h nocturnal period (8:00pm-8:00am) after 2 weeks under treatment |
| Daytime Total Sleep Time | Baseline, 14 days follow-up | Daytime Total Sleep Time (in minutes) during the 12h daytime period (8:00am-8:00pm) after 2 weeks under treatment |
| Differences between sleep efficiency between the two treatments. | Baseline, 14 days follow-up | Analyze possible differences between sleep efficiency between the two treatments after 2 weeks under treatment |
| Nighttime Number of Awakenings | Baseline, 14 days follow-up | Change in scores of nighttime number of awakenings from baseline to intervention weeks |
| Proportion of patients with gain of at least 30 minutes in Total Sleep Time | Baseline, 14 days follow-up | Proportion of patients with gain of at least 30 minutes in Total Sleep Time after 2 weeks under treatment |
Countries
Brazil
Outcome results
None listed