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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04614376
Other study ID # BCT_AD_001
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date November 2020
Est. completion date March 2022

Study information

Verified date November 2020
Source Bio Conscious Technologies Inc.
Contact Amir Hayeri, MSc
Phone +1-778-986-3030
Email amir@bioconscious.tech
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The Alzheimer's and Blood Glucose Levels Study is researching the differences in blood glucose levels between people with and without Mild Cognitive Impairment or Alzheimer's disease with the aim of early detection of Alzheimer's Disease.


Description:

This study will collect continuous glucose monitor (CGM) data from participants already using CGMs to better understand the relationship between Alzheimer's Disease and blood glucose levels. This study will use the " Endobits Companion " app for data collection. The Endobits Companion app is freely available for Android and iOS mobile devices, and was designed to keep track of patients diabetes management through a journal and relay this information with their CGM readings to their caring physician.


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date March 2022
Est. primary completion date August 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 50 Years and older
Eligibility Inclusion Criteria: - For the case group: have been diagnosed with MCI or AD within the past 5 years. - For the control group: have not been diagnosed with MCI or AD or another major dementia disease - Currently using a continuous glucose monitor (CGM). - Willing and able to provide informed consent, and to have their data collected through the Endobits Companion app. If the participant themself is unable to provide informed consent, it will be sought from their primary caregiver. Exclusion Criteria: - Patients younger than 50 years of age. - Patients with a BMI lower than 18 or higher than 35. - Patients with a major psychiatric illness (e.g., major depressive disorder, schizophrenia, bipolar disorder) - Patients diagnosed with another major dementia disease, including vascular dementia, Lewy Body disease, Huntington's disease, Creutzfeldt-Jakob disease, and Parkinson's disease.

Study Design


Locations

Country Name City State
Canada Bio Conscious Technologies Inc. Vancouver British Columbia

Sponsors (1)

Lead Sponsor Collaborator
Bio Conscious Technologies Inc.

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Blood Glucose Levels All participants will use continuous glucose monitors for the period of the study. The primary outcome is to determine the difference in mean values, variability, and other patterns in blood glucose levels between the case and control groups. As there is no intervention in this study, the difference between the case and control group will be measured over the entire study period. This will be measured throughout the study which is a period of up to 90 days.
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