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Ketone Supplement for Mild Cognitive Impairment (BREAK-AD Trial)
BREAK-AD Trial Summary
This trial will study the effects of a ketone supplement on brain function and metabolism in people with mild cognitive impairment.
BREAK-AD Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowBREAK-AD Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.BREAK-AD Trial Design
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Who is running the clinical trial?
Media Library
- I have had active cancer within the last 2 years.I have a chronic disease that is not well-managed.I have had kidney stones or high calcium levels in the past.You have had problems with alcohol and been dependent on it in the past two years.I have a history of heart problems.You are unable to have a scan that uses magnets or radioactive material to take pictures of your body.I have diabetes, regardless of its control level.My BMI is under 20 or I've lost more than 5% of my weight in the last 6 months without trying.I have a long-term digestive system condition like celiac or Crohn's disease.My kidney function is outside the normal range based on creatinine levels or GFR.You have allergies to soy, milk, gluten, or any ingredients in the study product.I am already taking a daily supplement for ketones or medium chain triglycerides.I am currently taking medication for muscle spasms or bladder issues.You have good eyesight and hearing abilities.I can understand, read, and speak French.Your QSP-9 score is higher than 19 out of 27.I have not been under general anesthesia in the past 6 months.I have recently changed my medication.I do not have significant memory loss or a disease like Alzheimer's.Your cognitive test score falls between 20 and 26 out of 30.I believe my memory is not as good as it used to be.
- Group 1: Open phase on active product
- Group 2: Active group
- Group 3: Placebo Group
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Are there any open enrollment opportunities for this medical experiment?
"Affirmative. Clinicaltrials.gov reports that recruitment for this scientific inquiry, which went live on October 15th 2020, is open at the moment. 56 individuals are required from a single location to participate in these trials."
Are participants under the age of 45 being considered for inclusion in this trial?
"As per the enrollment requirements, participants must be between 55 and 80 years of age."
How many individuals are eligible to partake in this trial?
"Affirmative. The clinicaltrials.gov page for this trial reveals that recruitment is still open, with the first post published on October 15th 2020 and a subsequent update taking place November 2nd 2020. 56 participants are required at one location to complete the study."
What criteria must a participant meet to be eligible for this trial?
"This clinical trial requires 56 participants aged between 55 and 80 who have been diagnosed with Mild cognitive impairment. Additionally, enrollees must provide a positive response to the question ''Do you think your memory is not as good as it was?'', possess a MoCA Score ranging from 20/30 to 25/30, receive 11 points for 16 years of education, 9 points for 8-15 years of education or 6 points 0-7 years of education., hold a QAF Score lower than 9/30, understand French in terms of reading comprehension and verbal communication abilities,,and demonstrate satisfactory visual acuity and hearing capacity."
What adverse effects have been reported to ensue from Active group treatments?
"The safety of the Active Group was assessed as a 2 out of 3 due to its Phase 2 status, which indicates that there are limited data supporting efficacy but some evidence suggesting safety."
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