Phase 2 Alzheimer's Disease Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• You (or your legal representative) are willing and able to give written permission to take part in the study
• You are male or female and currently living in a care facility
• You have been diagnosed with probable Alzheimer's Disease based on recognised medical guidelines
• You have had two or more episodes of agitation in the past 7 days that have disrupted social activities, required staff or medical help, or made daily tasks harder
• You scored at or above a certain level on an agitation rating scale (called the ABS) in the few days before joining the study (confirm with trial site)
• Your medications have not changed for at least 1 week before the screening appointment
• You scored 23 or below on a standard memory and thinking test called the Mini-Mental State Examination (MMSE)
• If you are female, you are not pregnant, not breastfeeding, not planning to become pregnant, and are using an accepted method of contraception or are no longer able to become pregnant
• If you are male with a female partner who could become pregnant, you are willing to use a reliable method of contraception during and for one month after the study
• Your body weight is over 50 kg and your body mass index (BMI) falls between 20 and 38
• You or your legal representative can understand and follow the study procedures for the full length of the study
• You have been living in the care facility for at least 7 days before screening and will continue to stay there through the end of all follow-up visits

Who may not be able to join:

• You have a known allergy or sensitivity to the study drug (dexmedetomidine) or any of its ingredients
• You have a skin problem such as scars, tattoos, burns, or wounds at the area where the study patch would be applied
• Your routine blood or lab tests show results that the study doctor considers a concern
• Your agitation is caused by being intoxicated with alcohol or drugs
• You have a significant risk of harming yourself or others, or you have answered "yes" to certain questions on a suicide risk assessment (confirm with trial site)
• You have tested positive for HIV, hepatitis B, or hepatitis C
• You have a significant medical history or current condition affecting your kidneys, liver, heart, metabolism, nervous system, or mental health that the doctor feels could be a problem — this includes heart failure, stomach ulcers, or gastrointestinal bleeding
• You have a history of migraines diagnosed by a doctor, frequent headaches (more than 5 per month), seizures, or you currently take anti-seizure medication
• You have a history of fainting or blackout episodes
• You have a history of your blood pressure dropping when you stand up, or you experience severe dizziness or fainting when standing
• Your heart tracing (ECG) shows a significant abnormality
• Your heart rate, or blood pressure readings (taken in lying, sitting, and standing positions) fall outside the acceptable ranges set by the study
• You have had a problem with alcohol or drug misuse in the past 5 years
• Your drug or alcohol test comes back positive at screening
• You are currently taking a medication that might interfere with the study drug in a way the doctor considers unsafe (certain medications are allowed if your dose has been stable for at least 30 days — confirm with trial site)
• You have used certain herbal or natural health products (such as St. John's Wort, kava, or valerian) within 7 days before starting the study drug
• You have had symptoms of an upper respiratory infection (such as a cold) within 7 days before starting the study drug
• You have used steroid tablets or injections within 7 days before starting the study drug (nasal sprays and skin creams are allowed)
• You have taken part in another clinical trial and received an experimental treatment within the past 30 days
• You have previously received the study patch (DMTS) in a clinical trial
• Your fall risk score is above 13 on the Johns Hopkins Fall Risk Assessment
• The study doctor feels for any reason that joining the trial would not be right for you

Important: Always verify eligibility with the trial site directly before applying.