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Also known as 12 cm2 - 2 Active DMTS Patches
12 cm2- 2 Active DMTS Patches · 1 trial · 1 indication
The ABS \[5\] is a 14-item scale developed to allow objective assessment of agitated behavior, particularly serial assessments for the evaluation of interventions to reduce agitation. The ABS Total Score ranges from 14 to 56. A total score of 21 or less is considered Normal; 22 to 28 is considered Mild; 29 to 35 Moderate; and 36 or more Severe Agitation.
| Arm | Type | Description |
|---|---|---|
| 12 cm2 - 2 Active DMTS Patches | ACTIVE_COMPARATOR | 2 Active DMTS patches will be applied to the upper back and worn for 4 days (96 hours) followed 14 days later with the same treatment for an additional 4-day treatment for subjects that are eligible for a second dosing. |
| 6 cm2 - 1 Active and 1 Placebo DMTS Patches | ACTIVE_COMPARATOR | 1 Active and 1 Placebo DMTS patches will be applied to the upper back and worn for 4 days (96 hours) followed 14 days later with the same treatment for an additional 4-day treatment period for subjects that are eligible for a second dosing. |
| Placebo - 2 Placebo DMTS Patches | PLACEBO_COMPARATOR | 2 Placebo DMTS patches will be applied to the upper back and worn for 4 days (96 hours) followed 14 days later with the same treatment for an additional 4-day treatment period for subjects that are eligible for a second dosing. |
| Name | Type | Description |
|---|---|---|
| 12 cm2 - 2 Active DMTS Patches | DRUG | 2 Active DMTS patches applied to the upper back followed 14 days later by another application of 2 Active DMTS patches. Each application will be worn for 4 days (96 hours) |
| 6 cm2 - 1 Active and 1 Placebo DMTS Patches | DRUG | 1 Active and 1 Placebo DMTS patches applied to the upper back followed 14 days later by another application of 1 Active and 1 Placebo DMTS patches. Each application will be worn for 4 days (96 hours) |
| Placebo - 2 Placebo DMTS Patches | DRUG | 2 Placebo DMTS patches applied to the upper back followed 14 days later by another application of 2 Placebo DMTS patches. Each application will be worn for 4 days (96 hours) |
Inclusion Criteria: 1. Voluntarily provide written informed consent (subject or legally authorized representative \[LAR\]). 2. Male or female, residing in a care facility. 3. Has a diagnosis of dementia of probable Alzheimer's Disease (AD) based on National Institute on Aging and the Alzheimer's As...
12 cm2- 2 Active DMTS Patches is an investigational small molecule being developed for the treatment of agitation. It is currently being studied in a Phase 2 clinical trial for agitation associated with dementia of the Alzheimer's type.
12 cm2- 2 Active DMTS Patches is being developed by BrainsWay Ltd., a company traded under the ticker BWAY. The drug is currently in Phase 2 clinical development for agitation.
12 cm2- 2 Active DMTS Patches is in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The ongoing trial is actively recruiting participants.
12 cm2- 2 Active DMTS Patches is being studied in a single Phase 2 trial with the identifier NCT06052254. The trial is titled 'Dexmedetomidine Transdermal Systems (DMTS) Treatment for Agitation Associated With Dementia of the Alzheimer's Type' and is recruiting 150 participants in the United States.
Yes, 12 cm2- 2 Active DMTS Patches is also known as 12 cm2 - 2 Active DMTS Patches. Both names refer to the same investigational drug being developed by BrainsWay Ltd. for the treatment of agitation.