Ignite Creation Date:
2024-05-05 @ 12:05 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00232570
Status:
UNKNOWN
Last Update Posted:
2009-05-05
First Post:
2005-09-30
Brief Title:
Quetiapine for the Treatment of Insomnia in Alzheimers Disease
Sponsor:
University of Vermont
Organization:
University of Vermont
Study Overview
Official Title:
Quetiapine for the Treatment of Insomnia Associated With Alzheimers Disease
Status:
UNKNOWN
Status Verified Date:
2009-05
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The primary hypothesis is that quetiapine will improve sleep in persons with Alzheimers Disease AD with higher doses producing greater total sleep time and sleep efficiency
Detailed Description:
Quetiapine is frequently used to treat psychosis in patients with Alzheimers disease AD and other dementias These patients commonly have sleep disturbances that include nighttime awakenings with confused agitated behaviors These awakenings impose a great challenge for caregivers especially family caregivers whose own sleep is disrupted as a result of the patients awakenings Sleep disturbance can lead to nursing home placement3 and may add to cognitive impairment of patients
There is no medication proven to be safe and effective in the treatment of sleep disorders in patients with dementia Antipsychotic medications are often prescribed at bedtime in the hopes that they will aid sleep and reduce agitation and psychosis associated with these awakenings Sleep disturbance is more common in AD patients with moderate to severe disease and these patients are more likely to have psychosis and to be recruited from long-term care facilities We recently conducted the only multicenter clinical trial of a drug for sleep disturbance in AD The study completed under the auspices of the NIAs Alzheimers Disease Cooperative Study investigated melatonin as a sedative-hypnotic agent for AD patients We found melatonin to be of no benefit on objective measures although there were positive trends in the data and a significant improvement on subjective measures caregiver ratings of patients sleep in one of the melatonin groups relative to placebo No other large trial in AD subjects has been reported in the literature for drugs with potential benefit for AD patients with sleep disturbances There are several reasons why this population needs to be specifically studied Patients with AD tend to have highly fragmented sleep with many nocturnal awakenings They have significant daytime sleepiness that might affect daytime cognitive function and behavior These patients tend to be older with sensitivity to drug side effects
People with neurodegenerative diseases such as AD may respond differently to CNS-active medications Finally this population represents a large and growing cohort of patients that deserve individual study of their unique problems
There is no medication proven to be safe and effective in the treatment of sleep disorders in patients with dementia Antipsychotic medications are often prescribed at bedtime in the hopes that they will aid sleep and reduce agitation and psychosis associated with these awakenings Sleep disturbance is more common in AD patients with moderate to severe disease and these patients are more likely to have psychosis and to be recruited from long-term care facilities We recently conducted the only multicenter clinical trial of a drug for sleep disturbance in AD The study completed under the auspices of the NIAs Alzheimers Disease Cooperative Study investigated melatonin as a sedative-hypnotic agent for AD patients We found melatonin to be of no benefit on objective measures although there were positive trends in the data and a significant improvement on subjective measures caregiver ratings of patients sleep in one of the melatonin groups relative to placebo No other large trial in AD subjects has been reported in the literature for drugs with potential benefit for AD patients with sleep disturbances There are several reasons why this population needs to be specifically studied Patients with AD tend to have highly fragmented sleep with many nocturnal awakenings They have significant daytime sleepiness that might affect daytime cognitive function and behavior These patients tend to be older with sensitivity to drug side effects
People with neurodegenerative diseases such as AD may respond differently to CNS-active medications Finally this population represents a large and growing cohort of patients that deserve individual study of their unique problems
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None