Virtual Clinical Trials in Alzheimer’s Disease

Clinical trials for Alzheimer’s disease carry a lot of biases. For the patients, changing their habits to go and participate in a visit for a trial can be very troubling. Having to commute, sometimes for 2 hours or more, and wait in an unfamiliar environment, is both tyring and distressing. Evaluation of disease severity can be affected by the stress. Both groups (control and IP) are evaluated in the same way, but this context can lead to a “noise” that may flatten any effect of a product. Also, depending on the patient, the stage of their disease, their past and present ability to cope with stress, answers to questions in an interview can be more or less affected and then again induce a higher variability of answers.

Remote consultation is then the best alternative to on-site visit. This also allows them to recruit patients in a larger perimeter than a couple of hours drive from the investigation center.

When the endpoint is measured through an interview with a caretaker, this bias is less important, yet the caretaker’s life will be easier if they can answer a survey without having to take half or a full day to organise and participate in the visit. Completing questionnaires from their own device will make it less burdensome and increase compliance.

At Healint, we are determined to improve the life of anyone who suffers, and Alzheimer’s disease being more and more prevalent, we aim at accelerating the discovery of new treatments for this pathology.

CDR

(ClinRO)

The Clinical Dementia Rating is an instrument used in clinical and research settings to assess the severity of Alzheimer’s disease. The CDR rates the severity of AD using a 5-point scale that rates the severity of signs and symptoms as they affect the patient’s ability to function in the 6 cognitive categories of memory, orientation, judgment and problem solving, community affairs/ involvement, home life and hobbies, and personal care. The CDR is completed by the researcher or a clinician after performing a face-to-face, semi-structured interview with the patient and a reliable informant (caretaker or family member). Healint provides a support for this interview and runs the algorithm to calculate the score, as a sum of boxes, or using an algorithm that weights memory more heavily than the other categories. This allows us to reduce the risk of human error. We also provide the possibility to recall answers from the caretaker, in order to make it easier for the clinician when interviewing the patient.

MMSE

(ClinRO)

The Mini Mental State Examination is used to measure thinking ability, it is not a diagnosis tool. Widely used in Alzheimer’s disease trials, it can also be used in other indications in which a cognitive endpoint is needed. While designed to be administered in a doctor’s office or clinical setting, the MMSE is a short and effective test that can also be taken in the home with the help of a family member, especially for the questions that require the subject to use a paper and pencil. Our HeRO™ platform guides the clinician and the caretaker to conduct the test.

ADAS-Cog

(ClinRO)

The Alzheimer's Disease Assessment Scale-Cognitive Subscale is an 11 to 13-questions neuropsychological assessment used to assess the severity of cognitive symptoms of dementia. It is one of the most widely used cognitive scales in clinical trials. Some of the questions require the patient to draw. With the help of a family member the interview with the clinician can be performed remotely, when the patients are in the comfort of their familiar environment. A central evaluation by a limited number of assessors reduces variability and thus reduces background noise and increase confidence in the quality of the result. It also allows to recruit patients located far from the investigation center and work in the preferred language of the participants.

NPI

(ClinRO)

The purpose of the Neuropsychiatric Inventory is to obtain information on the presence of psychopathology in patients with brain disorders. The NPI was developed for application to patients with Alzheimer’s disease and other dementias, but it may be useful in the assessment of behavioral changes in other conditions. The NPI is based on responses from an informed caregiver and preferably conducted in the absence of the patient. Our HeRO™ tool allows us to collect the results without having to commute to the site, simply during a visio consultation.