CognivAiD Real-World Evidence Clinical Registry (CONNECT Registry)

Moleac

Status: Enrolling

Conditions: Dementia, Vascular; Memory Impairment

Treatments: Other: CognivAID (Sailuotong)

Study type: Observational

Funder types: Industry

Identifiers

NCT06228638

SAFE2022_01

Details and patient eligibility

About

This is an observational, prospective cohort of patients who were prescribed or have taken CognivAiD as prescribed by the attending physician. The safety and efficacy of CognivAiD have been established in clinical studies. The registry will assess the safe use and effectiveness of CognivAiD in a real-world setting. The registry is designed as a product registry in clinical practice. The design also takes into account the different scenarios of product use in the real world (e.g., switching therapies during follow-up, use of multiple products in combination or sequence, different dosing, and compliance).

Full description

While the safety and efficacy of CognivAiD is established in clinical studies, this registry will assess the safe use and effectiveness of CognivAiD in the real-world setting. The design also takes into account the different scenarios of product use in the real world (e.g., switching therapies duObjectivesThe primary objective of this registry is to evaluate the use, safety, and effectiveness of CognivAiD This project is not a clinical trial wherein an active intervention intended to change human subject's outcome is implemented and takes decision-making away from the physician and patient. This registry uses an observational study design that does not specify or assign treatments or therapies. The registry is designed by keeping as closely as possible to real-world practice and as unobtrusive as possible to closely reflect usual practice and normal standards of care.

There are few inclusion and exclusion criteria to include a broad range of participants to make the results more generalizable. Participants are observed as they present for care and the data collected reflects existing tests, measurements, and treatments a healthcare provider customarily uses. Participation in the registry is entirely voluntary.

The primary objective of the registry is to evaluate the use, safety, and effectiveness of CognivAiD in a real-world setting. The primary data elements include the reporting of side effects and adverse events. Data collection and includes demographics, education, number of years, past medical history, CognivAiD information and, neurological status by the standard clinical practice and normal standard of care. Cognitive Assessment will be performed as per routine clinical visit. Collected data will be entered into the online study database.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Male or female
• Legal age as per country requirement
• Already taking or having to receive a prescription for CognivAiD (decision must have been made before consideration to participate in the registry)
• Agrees to be included in the registry, provides written consent inclusion criteria
• Male or female
• Legal age as per country requirement
• Already taking or having to receive a prescription for CognivAiD (decision must have been made before consideration to participate in the registry)
• Agrees to be included in the registry, provides written consent, and allows retrieval and analysis of data by local requirements.