Alzheimer DiseaseNCT00291421
A Survey Study of the Treatment and Outcome Management in Patients Diagnosed With Alzheimer's Disease
An observational study of Alzheimer Disease and Dementia, run by Janssen Pharmaceutica N.V., Belgium.
Trial summary
The purpose of this study is to collect and compare information regarding the treatment and outcome of patients diagnosed with Alzheimer's disease who are receiving either drug or nondrug treatment. Information will be collected from patients and their primary caregivers. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Alzheimer Disease, Dementia, Nervous System Diseases
- How many people
- 2,360 participants
- Where
- No sites listed yet
- Study dates
- Jul 2002to May 2006
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients diagnosed with new or previous mild or moderate Alzheimer's disease diagnosed by a doctor according to medically-accepted definitions
- Patients living in ordinary households (for example in their own home or in the home of a family member or friend, not in nursing homes or other long-term care facilities)
Who cannot join
- Patients who are currently participating in another clinical trial
About this study
Official title: International Outcomes Survey In Dementia (IOSID)
The purpose of this study is to collect and compare information regarding the treatment and outcome of patients diagnosed with Alzheimer's disease who are receiving either drug or nondrug treatment. Information will be collected from patients and their primary caregivers.
Read the 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 Alzheimer's disease. Over time, patients with Alzheimer's 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 homes.Treatments 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 population.This study is a large-scale survey that will provide information related to the treatment of Alzheimer's disease, including information regarding treatment patterns, characteristics of patients with Alzheimer's 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 Alzheimer's 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 Alzheimer's 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 Alzheimer's disease. Patients receiving treatment with one of the following medications approved for treatment of Alzheimer's 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 Alzheimer's 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-being/general 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 Alzheimer's 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 Alzheimer's 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
- Keywords
- Alzheimer's Disease, Dementia, Brain Disease, Memory Loss, Caregiver, Primary Caregiver, Observation, galantamine, donepezil, rivastigmine, Quality of life
- Medical subject headings
- Alzheimer Disease, Dementia, Nervous System Diseases, Mental Disorders, Brain Diseases, Memory Disorders
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2006 (estimated)
- Study startJul 2002
- Study completionMay 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 2,360 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen Pharmaceutica N.V., Belgium
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Janssen Pharmaceutica N.V. Clinical Trial, Study director, Janssen Pharmaceutica N.V.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00291421
- Sponsor's protocol ID
- CR003937
- Status last verified
- Apr 2013
- First submitted
- 10 Feb 2006
- Last updated
- 16 Apr 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- International Outcomes Survey In Dementia (IOSID)
- ClinicalTrials.gov ID
- NCT00291421
- Acronym / sponsor ID
- CR003937
- Keywords
- Alzheimer's Disease, Dementia, Brain Disease, Memory Loss, Caregiver, Primary Caregiver, Observation, galantamine
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,360 participants (actual)
- Lead sponsor
- Janssen Pharmaceutica N.V., BelgiumIndustry (pharma, biotech, devices)
- Study start
- Jul 2002
- Study completion
- May 2006 (actual)
- First posted
- 14 Feb 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to collect and compare information regarding the treatment and outcome of patients diagnosed with Alzheimer's 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 Alzheimer's disease. Over time, patients with Alzheimer's 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 homes.Treatments 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 population.This study is a large-scale survey that will provide information related to the treatment of Alzheimer's disease, including information regarding treatment patterns, characteristics of patients with Alzheimer's 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 Alzheimer's 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 Alzheimer's 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 Alzheimer's disease. Patients receiving treatment with one of the following medications approved for treatment of Alzheimer's 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 Alzheimer's 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-being/general 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 Alzheimer's 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 Alzheimer's 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 design
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Patients diagnosed with new or previous mild or moderate Alzheimer's disease diagnosed by a doctor according to medically-accepted definitions
- Patients living in ordinary households (for example in their own home or in the home of a family member or friend, not in nursing homes or other long-term care facilities)
Key exclusion criteria (1 listed)
- Patients who are currently participating in another clinical trial
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2013.
Related trials for Alzheimer Disease
Not yet recruiting
Virtual Reality to Advance Dementia Care and Quality of Life
Dementia, Agitation
RecruitingPhase 2
Neuroplasticity Enhancement From Cognitive Training Reinforced by Psilocybin
Alzheimer's Disease
RecruitingObservational study
Amyloid PET Imaging in the Baltimore Longitudinal Study of Aging
Aging
Recruiting
The Effects of Successful OSA Treatment on Memory and AD Biomarkers in Older Adults Study
Obstructive Sleep Apnea, Cognitive Decline
Active, not recruiting
Promoting Physical Activity in Older Hispanic/Latino(a) Adults
Sedentary Behavior, Physical Inactivity
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janssen Pharmaceutica N.V. Clinical Trial study director
Janssen Pharmaceutica N.V.
Questions about this trial
What is this clinical trial studying?
An observational study of Alzheimer Disease and Dementia, run by Janssen Pharmaceutica N.V., Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2013.