Mild Cognitive ImpairmentNCT04614376
Alzheimer's and Blood Glucose Levels
An observational study of Mild Cognitive Impairment and Alzheimer Disease, run by Bio Conscious Technologies Inc. at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Mild Cognitive Impairment, Alzheimer Disease
- How many people
- 100 participants
- Where
- 1 siteCanada
- Study dates
- Nov 2020to Mar 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study population is drawn from older individuals (at least 50 years of age) with or without MCI or AD.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Bio Conscious Technologies Inc.
Vancouver, British Columbia, V6B 4N6
Amir Hayeri, MSc, 1-778-986-3030, amir@bioconscious.tech
About this study
Official title: A Machine Learning Approach to Alzheimer's Detection From Continuous Blood Glucose Monitoring Data
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.
Read the detailed 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.
- Conditions
- Mild Cognitive Impairment, Alzheimer Disease
- Medical subject headings
- Cognitive Dysfunction, Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | The control group participants have not been diagnosed with mild cognitive impairment or Alzheimer's disease within the past 5 years. There are no interventions to this group. | |
| Case Group | The case group participants have been diagnosed with mild cognitive impairment or Alzheimer's disease within the past 5 years. There are no interventions to this group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: This will be measured throughout the study which is a period of up to 90 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2020
- Study startNov 2020 (estimated)
- Primary completionAug 2021 (estimated)
- Study completionMar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Cognitive ImpairmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bio Conscious Technologies Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04614376
- Sponsor's protocol ID
- BCT_AD_001
- Status last verified
- Nov 2020
- First submitted
- 13 Oct 2020
- Last updated
- 4 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Machine Learning Approach to Alzheimer's Detection From Continuous Blood Glucose Monitoring Data
- ClinicalTrials.gov ID
- NCT04614376
- Acronym / sponsor ID
- BCT_AD_001
- Conditions
- Mild Cognitive Impairment, Alzheimer Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Bio Conscious Technologies Inc.Industry (pharma, biotech, devices)
- Study start
- Nov 2020 (estimated)
- Primary completion
- Aug 2021 (estimated)
- Study completion
- Mar 2022 (estimated)
- First posted
- 4 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | – | –The control group participants have not been diagnosed with mild cognitive impairment or Alzheimer's disease within the past 5 years. There are no interventions to this group. |
| Case Group | – | –The case group participants have been diagnosed with mild cognitive impairment or Alzheimer's disease within the past 5 years. There are no interventions to this group. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study population is drawn from older individuals (at least 50 years of age) with or without MCI or AD.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Blood Glucose Levels
Time frame: This will be measured throughout the study which is a period of up to 90 days.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mild Cognitive Impairment and Alzheimer Disease, run by Bio Conscious Technologies Inc. at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Amir Hayeri, MSc (+1-778-986-3030, amir@bioconscious.tech), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood Glucose Levels (time frame: This will be measured throughout the study which is a period of up to 90 days.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2020.