Alzheimer's Registry

Официальное название

PPD™ CorEvitas™ International Alzheimer's (ALZ) Drug Safety and Effectiveness Registry

Обзор

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.

Подробное описание

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

Первичные конечные точки

• Alzheimer Disease Epidemiology and presentation [Срок оценки: Every 6 months for 10 years]
• Alzheimer Disease management, and outcomes [Срок оценки: Every 6 months for 10 years]

Критерии участия

Критерии включения

To be eligible to participate in this registry, an individual must meet all the following criteria (determined by the investigator):

• Has been diagnosed with mild cognitive impairment (MCI), early symptomatic Alzheimer's disease, Alzheimer's disease, or dementia with clinical suspicion of Alzheimer's disease.
• Subject is at least 18 years of age or older and has attained the legal age for consent to procedures involved in the research, under the applicable law of the jurisdiction in which the research is being conducted at the time of enrollment.
• Has care partner(s) willing to participate as a source of information who maintains regular contact with the subject (defined as at least ten hours per week), will accompany the subject to the clinic visits, has attained the legal age for consent under the applicable law of jurisdiction in which the research is being conducted at the time of consent, and is willing and able to provide informed consent as the care partner.
• Subject has the ability to understand the purpose, risks, and voluntariness of Registry participation and is willing and able to provide informed consent
• For US subjects only, must be willing and able to provide Personally Identifiable Information (full legal name, sex at birth, date of birth, home address zip/postal code, and social security number at a minimum).
• Has been prescribed (and intends to initiate) a commercially available therapy for the treatment of Alzheimer's disease (or symptoms of Alzheimer's disease) (Eligible Medication) at the time of enrollment.

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.

Критерии исключения

An individual who meets any of the following criteria will be excluded from participation in the registry:

• Is participating or planning to participate in a double-blind randomized clinical trial for a MCI or AD.
• Has been previously treated with an ATT prior to enrollment into the registry

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

США · 1 центр

• CorEvitas, LLC — Waltham

Идентификаторы

NCT: NCT07420075 · CorEvitas-ALZ-710

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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