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The design is an open-ended, prospective, observational, (non-interventional) registry for subjects with mild cognitive impairment (MCI), early symptomatic Alzheimer's disease, Alzheimer's disease, or dementia with clinical suspicion of Alzheimer's disease under the care of a neurologist, psychiatrist, geriatrician or other qualified provider. Longitudinal data are collected from subjects, their care partner(s), and their treating healthcare provider during routine clinical encounters using a structured and standardized data collection method. Approximately 2,000 subjects, with no defined upper limit, across around 75 clinical sites worldwide will be recruited.
The objective of the registry is to create a prospective cohort of Alzheimer's disease subjects to evaluate long-term real-world safety and effectiveness of standard of care treatments for Alzheimer's disease. Data collected through the registry may be used to address a range of research questions and use cases, including but not limited to: Evaluating the effectiveness and safety of commercially available medications for the treatment of Alzheimer's disease, Providing information to support ongoing risk-benefit evaluation by drug manufacturers and regulators, Research related to drug utilization, disease burden, and unmet needs and Supporting post-authorization safety studies to generate evidence related to real world safety of medications used for the treatment of the disease(s) under study
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| Measure | Description | Time Frame |
|---|---|---|
| Alzheimer Disease Epidemiology and presentation | The major clinical outcome include an assessment of the epidemiology of Alzheimer's Disease; to better understand the presentation and natural history. | Every 6 months for 10 years |
| Alzheimer Disease management, and outcomes | The major clinical outcome include an assessment of the epidemiology of Alzheimer Disease; to better understand the management and outcomes. | Every 6 months for 10 years |
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Inclusion Criteria:
To be eligible to participate in this registry, an individual must meet all the following criteria (determined by the investigator):
Note: Participation in the registry will not interfere with the standard of care provided by the subject's treating clinician. Investigators retain independent clinical judgment in managing patient care.
Exclusion Criteria:
An individual who meets any of the following criteria will be excluded from participation in the registry:
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Subjects enrolled in this registry will be treated according to routine clinical care; treatments are prescribed at the provider's discretion and the decision to treat the subject with a drug is made prior to and independently of study participation. The clinician will determine subject visit schedules according to routine practice, patient needs,and local standard of care (SoC)
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CorEvitas, LLC | Waltham | Massachusetts | 02451 | United States |
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| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| D024801 |
| Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |