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Dexmedetomidine for Dementia
Study Summary
This trial will test a drug for treating agitation in people with dementia, up to 168 doses in 12 weeks.
- Agitation
- Dementia
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2020 Phase 4 trial • 798 Patients • NCT02004613Trial Design
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- You have episodes of restlessness and uncontrolled movements.You have memory problems that are not caused by Alzheimer's disease.You have abnormal lab test results or ECG readings.You are currently using drugs or alcohol excessively.You have experienced recent agitation and confusion that may be related to a medical condition.You must have been diagnosed with probable Alzheimer's disease according to specific medical criteria from either 2018 or 2011.If there is evidence that a stroke is linked to the decline in thinking and memory, a person may not be included in the study for probable Alzheimer's disease.The doctor thinks you might be at risk of hurting yourself or someone else.You are currently not in good health or are recovering from a medical condition. If you had a stroke over 5 years ago, you might still be able to participate.You are currently agitated due to being intoxicated.The person shows signs of agitation that are different from their usual behavior, as defined by a specific association.You have severe difficulties with memory and need a lot of help with everyday tasks.You have had fainting episodes or low blood pressure in the past 2 years, or you currently have low blood volume or low heart rate.
- Group 1: Cohort 1- 40 Micrograms
- Group 2: Cohort 2- 60 Micrograms
- Group 3: Placebo
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- 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
What hazards are associated with a Cohort 1- 40 Micrograms protocol?
"Based on the available research, Cohort 1- 40 Micrograms received a score of 3 in terms of safety. This is due to Phase 3 trials that have been conducted with positive results both in efficacy and overall risk assessment."
Are there still available opportunities to participate in this research?
"As indicated on clinicaltrials.gov, the recruitment for this medical trial is still ongoing; it was initially posted on December 14th 2022 and recently updated on December 16th 2022."
What is the maximum capacity of participants for this trial?
"Correct. The clinicaltrials.gov database implies that this experiment is accepting patients, with the original posting dating back to December 14th 2022 and last updated on December 16th 2022. This research requires 150 individuals to be recruited at one study site."
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