Ignite Creation Date:
2024-05-06 @ 8:01 PM
Last Modification Date:
2024-10-26 @ 3:19 PM
Study NCT ID:
NCT06228638
Status:
RECRUITING
Last Update Posted:
2024-01-31
First Post:
2024-01-15
Brief Title:
CognivAiD Real-World Evidence Clinical Registry CONNECT Registry
Sponsor:
Moleac Pte Ltd
Organization:
Moleac Pte Ltd
Study Overview
Official Title:
CognivAiD Real-World Evidence Clinical Registry
Status:
RECRUITING
Status Verified Date:
2024-01
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:
CONNECT
Brief Summary:
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 eg switching therapies during follow-up use of multiple products in combination or sequence different dosing and compliance
Detailed 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 eg 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 subjects 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None