NeuroAiD™ Safe Treatment Registry

What is the NeST Registry?

The NeST Registry is a pro-active and voluntary initiative of Moleac to monitor the safe use of NeuroAiD, NeuroAiD II, Nu-rAiD, or NurAiD II (collectively referred to as NeuroAiD in this registry) in patients who are taking it. While NeuroAiD has been shown to be very safe in published clinical trials, it would be helpful to assess its safe use in the real world setting.

Which patients may be included in the NeST Registry?

Any patient who is taking, or has been prescribed, NeuroAiD may be included in the registry. These patients have medical conditions that would have been deemed suitable for treatment with NeuroAiD by the physician and/or the patient.
It is expected that most patients included in the registry would have suffered a stroke, traumatic brain injury, or an hypoxic event to the brain. Patients taking NeuroAiD for other medical or neurological conditions may likewise be included in the registry.

Is it required for all patients taking NeuroAiD to be included in the registry?

Inclusion in the NeST Registry is entirely voluntary and is not a requirement for all patients taking NeuroAiD. An agreement from the patient or responsible person would be obtained before participation in the registry.

Why are patients encouraged to participate in this registry?

Feedbacks would be sent centrally to Moleac and the collective information may become helpful for other patients. By participating in the NeST registry, more uniform and reliable information can be collected from patients who are actually taking NeuroAiD. It is well known that waiting for spontaneous reporting captures only an extremely small percentage of actual events.

How long would each patient's participation be?

While patient participation is voluntary, it is hoped that they would stay in the program for at least 3 months or as long as they are still taking NeuroAiD™.

What kind of information will be collected from patients?

Information that is important in assessing safety will be collected. This include information on demographics, medical reason for taking NeuroAiD™, concomitant medical conditions, current neurological and functional status, NeuroAiD™ intake, side effects experienced, and concomitant medications.

When should patient information be collected?

Baseline information should be collected before the start of NeuroAiD™. Follow-up information will be obtained monthly for the first 3 months (whenever possible), and during subsequent visits thereafter (coincident with the patient's regular follow-up visits) while the patient is still taking NeuroAiD™.

How will patient information be collected?

Patient information would be collected by paper report forms or by online submission.

Will personal details and medical information be available for other people to see?

Data would be maintained in a secured database kept in Moleac Singapore and accessible only to relevant personnel.
Patient identity will be recorded only as initials. Specific individual information in the registry would not be shared with other persons, entities, or companies. Collective anonymized information will be summarized and reviewed. These summaries may be presented to medical practitioners and/or published in medical journals. Local authorities may require submission of summary information for their internal use, as well

Is any approval needed for this registry?

Local requirements for surveillance of a marketed product would be followed. Inclusion of patients in the registry may be started immediately if no specific approval is required. In certain situations, the regulatory authorities may conditionally mandate or may give approval to carry out the registry. If hospital ethics committee or institutional review board approval is necessary, an expedited review would be requested because of the very low-risk nature of this registry