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New treatment option for Agitation
Official title Dexmedetomidine Transdermal Systems (DMTS) Treatment for Agitation Associated With Dementia of the Alzheimer's Type
ClinicalTrials.gov ID: NCT06052254
What this study is testing
What is 12 cm2 - 2 Active DMTS Patches?
12 cm2 - 2 Active DMTS Patches is an investigational medicine, being studied as a potential treatment for agitation.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The primary objective of this study is to evaluate the efficacy of DMTS on frequency and severity of agitation associated with dementia of the Alzheimer's type, compared with placebo.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Adults
You may be able to join if
- Voluntarily provide written informed consent (subject or legally authorized representative [LAR]).
- Male or female, residing in a care facility.
- Has a diagnosis of dementia of probable Alzheimer's Disease (AD) based on National Institute on Aging and the Alzheimer's Association (NIA-AA)...
- Had two or more episodes (using a 7-day lookback period) of agitation that impairs social activities, requires staff or medical intervention, or...
- Had an ABS total score ≥ 22 at least once during Day -4 to Day -1 when assessing eligibility on Day 1 Pre-randomization.
You likely can't join if
- Has a known sensitivity to dexmedetomidine or any excipient in the DMTS/placebo.
- Has a skin abnormality (eg, scar, tattoo) or unhealthy skin condition (eg, burns, wounds) at the DMTS/matching placebo application site, according to...
- Has a clinically significant abnormal clinical laboratory test value as determined by the investigator.
- Has agitation caused by acute intoxication.
- Has significant risk of suicide or homicide per investigator's assessment, or any patient with an answer of "yes" to Items 4 or 5 on the...
- Has a history of or positive test results for the human immunodeficiency virus (HIV), hepatitis B, or hepatitis C.
See the full eligibility criteria
Who can join
- Voluntarily provide written informed consent (subject or legally authorized representative [LAR]).
- Male or female, residing in a care facility.
- Has a diagnosis of dementia of probable Alzheimer's Disease (AD) based on National Institute on Aging and the Alzheimer's Association (NIA-AA) criteria (2018). The clinical diagnosis of "probable Alzheimer's Disease...
- Had two or more episodes (using a 7-day lookback period) of agitation that impairs social activities, requires staff or medical intervention, or impairs ability for functional activities of daily living at Screening.
- Had an ABS total score ≥ 22 at least once during Day -4 to Day -1 when assessing eligibility on Day 1 Pre-randomization.
- Has gone a minimum of 1 week with no change in medication prior to Screening.
- Has a score of ≤ 23 on the Mini-Mental State Examination (MMSE) at Screening.
- Female people who are:
- Not pregnant, not lactating, and not planning to become pregnant during the study or for 1 menstrual cycle thereafter and
- Surgically sterile; or postmenopausal (ie, amenorrhea for ≥2 years as reported by subject/caregiver; postmenopausal status will be confirmed with FSH test); or have a monogamous partner who is surgically sterile; or...
- Male people who have female sex partners of childbearing potential must be surgically sterile or commit to use a reliable method of birth control during the study and for 1 month following the study. Reliable...
- Has a body weight \> 50 kg, and body mass index of 20 to 38 kg/m2, inclusive.
- Subject or LAR able to understand the study procedures, comply with all study procedures, and agree to participate in the study program for its full duration.
- Has lived in facility for at least 7 days prior to screening and will remain in facility through the completion of Follow-Up assessments.
What rules you out
- Has a known sensitivity to dexmedetomidine or any excipient in the DMTS/placebo.
- Has a skin abnormality (eg, scar, tattoo) or unhealthy skin condition (eg, burns, wounds) at the DMTS/matching placebo application site, according to examination by the investigator at screening.
- Has a clinically significant abnormal clinical laboratory test value as determined by the investigator.
- Has agitation caused by acute intoxication.
- Has significant risk of suicide or homicide per investigator's assessment, or any patient with an answer of "yes" to Items 4 or 5 on the Columbia-Suicide Severity Rating Scale (C-SSRS).
- Has a history of or positive test results for the human immunodeficiency virus (HIV), hepatitis B, or hepatitis C.
- Has a clinically significant history or clinically significant manifestation of any of the following, as determined by the investigator: a renal (including an estimated glomerular filtration rate [eGFR] below the...
- Has a history of physician-diagnosed migraine, frequent non-vascular headaches (\> 5 per month), seizures, or are currently taking anticonvulsants.
- Has a history of syncope or other syncopal attacks.
- Has present and/or significant history of postural hypotension (determined through examination by the investigator or designee) or history of severe dizziness or fainting on standing in the opinion of the investigator.
- Has evidence of a clinically significant 12-lead ECG abnormality.
- Has an average heart rate \ 100 bpm, systolic blood pressure (BP) \ 140 mmHg, or diastolic BP \ 90 mmHg, measured in 3 sequential positions (supine after 5 minutes; sitting after 1 minute; and standing after 2 minutes)...
- Has a history of alcohol abuse or prescription/illicit drug abuse within the previous 5 years.
- Has positive results on the urine drug screen or alcohol breath test indicative of drugs of abuse or alcohol use at screening.
- Is receiving concurrent therapy that can interfere with the evaluation of how well it works or safety, such as any drug that in the investigator's opinion may exert significant synergistic interactions with...
- Uses any natural health products (including chaparral, comfrey, germander, jin bu huan, kava, pennyroyal, skullcap, St. John's wort, or valerian, and excluding vitamins or mineral supplements) within 7 days prior to...
- Had symptoms of an upper respiratory tract infection within 7 days prior to dosing of the study drug.
- Utilized oral or injectable corticosteroids within 7 days prior to dosing of the study drug (intranasal and topical corticosteroid use during this time period is allowed).
- Received any investigational product within 30 days prior to dosing of the study drug.
- Received DMTS in a previous clinical trial.
- Has a Johns Hopkins Fall Risk Assessment Score of \> 13.
- In the opinion of the investigator or designee, is considered unsuitable for study entry and/or is unlikely to comply with the study protocol for any reason.
The study team makes the final eligibility decision.
Where it's taking place
- Daytona Beach, Florida, United States
- Miami, Florida, United States
- St. Petersburg, Florida, United States
- Springfield, Massachusetts, United States
- Worcester, Massachusetts, United States
- Toms River, New Jersey, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, not specified. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Daytona Beach, Florida, United States; Miami, Florida, United States; St. Petersburg, Florida, United States; Springfield, Massachusetts, United States; Worcester, Massachusetts, United States; Toms River, New Jersey, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.