Ignite Creation Date:
2024-05-05 @ 4:41 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00291421
Status:
COMPLETED
Last Update Posted:
2013-04-16
First Post:
2006-02-10
Brief Title:
A Survey Study of the Treatment and Outcome Management in Patients Diagnosed With Alzheimers Disease
Sponsor:
Janssen Pharmaceutica NV Belgium
Organization:
Janssen Pharmaceutica NV Belgium
Study Overview
Official Title:
International Outcomes Survey In Dementia IOSID
Status:
COMPLETED
Status Verified Date:
2013-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to collect and compare information regarding the treatment and outcome of patients diagnosed with Alzheimers disease who are receiving either drug or nondrug treatment Information will be collected from patients and their primary caregivers
Detailed Description:
Dementia is a chronic progressive brain disease that may involve a number of symptoms including memory loss and changes in personality behavior judgment attention span language and thought The most common type of dementia is Alzheimers disease Over time patients with Alzheimers disease may lose ability to perform daily tasks related to personal care for example bathing dressing eating and may be unable to handle money or travel to familiar places Dementia is one of the main reasons people are admitted to long-term care in residential or nursing homesTreatments or services that prevent or delay admission into these institutions are important because they may help decrease or delay the use of health or social care resources that are increasing in a growing elderly populationThis study is a large-scale survey that will provide information related to the treatment of Alzheimers disease including information regarding treatment patterns characteristics of patients with Alzheimers disease estimates of costs of care disease outcomes patients ability to function daily and quality of life for caregivers This study will examine the current management of patients with mild and moderate Alzheimers disease in real life settings As opposed to a clinical trial in which a particular group of patients is selected to participate and where treatments may be specified and possibly compared with a placebo an inactive substance this study will include a wider variety of patients and treatment options to more closely represent the management of Alzheimers disease in current clinical practice Information will be collected from patients in Europe and other countries who are being treated by a doctor for mild to moderate Alzheimers disease Patients receiving treatment with one of the following medications approved for treatment of Alzheimers disease galantamine donepezil rivastigmine or tacrine and patients receiving nondrug treatment disease progression monitoring ginkgo extracts Vitamin E estrogen etc may participate No treatment or procedures will be specified and no medication will be provided by the Sponsor of this study Treatment of Alzheimers disease may be stopped started or changed by the patients individual doctors as appropriate Information regarding disease status treatment behavior ability to function and use of social care services day care home care meals on wheels social work will be collected from patients Information regarding quality of sleep of the patient and caregiver amount of care required by the patient and well-beinggeneral quality of life will be collected from caregivers Information will be collected every 6 months for a period of 2 years with a possible additional follow-up period of 2 years If a patient in the study dies the collection of information will stop If a patient in the study is permanently admitted to a supported care nursing home or residential care facility collection of information will stop but follow-up with the caregiver will be conducted at the end of the 2-year survey to determine if the patient is alive or deceased The study hypothesis is that treatment of Alzheimers disease with medication may improve patient status reduce caregiver dependency improve caregiver quality of life reduce the amount of social care services needed and prolong or prevent admission to long-term institutions of patients with Alzheimers disease Since the study involves only collection of information no treatment will be required by the Sponsor and no medication will be supplied by the Sponsor
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