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Label indication EXELON PATCH is an acetylcholinesterase inhibitor indicated for treatment of: • Mild, moderate, and severe dementia of the Alzheimer’s type (AD). ( 1.1 ) • Mild-to-moderate dementia associated with Parkinson’s disease (PD). ( 1.2 ) 1.1 Alzheimer’s Disease EXELON PATCH is indicated for the treatment of dementia of the Alzheimer’s type (AD). FDA label
Also known as Rivastigmine Patch, Rivastigmine transdermal patch, Rivastigmine capsule, ENA713
Rivastigmine · 10 trials · 7 indications
The primary variable of this study is the percentage of patients having an AE leading to study drug discontinuation during the 24-week double-blind treatment period.
The Alzheimer's Disease Assessment Scale (ADAS) is a performance-based test that measures specific cognitive and behavioral dysfunctions in patients with Alzheimer's Disease. The cognitive subscale of the ADAS (ADAS-Cog) comprises 11 items that are summed to a total score ranging from 0 to 70, with lower scores indicating less severe impairment. It was assessed by a mental health professional (e.g., M.D., Ph.D., Pharm.D., R.N., or other equivalent qualifications) with a minimum of 2 years research experience meeting certification requirements.
The AEs were summarized by presenting the number and percentage of patients having any of the 4 AEs or discontinued due to any of the 4 predefined AEs (tremor, muscle rigidity, bradykinesia, and fall)in each treatment group. The 95% CIs associated with the rates were also presented.
The discontinuations due to these AEs were summarized by presenting the number and percentage of patients having any of the 4 AEs or discontinued due to any of the 4 predefined AEs (tremor, muscle rigidity, bradykinesia, and fall) in each treatment group. The 95% CIs associated with these rates were also presented.
The Alzheimer's Disease Assessment Scale - Japan cognitive subscale (ADAS-J cog) was used to measure change in cognitive function. The ADAS-J cog score ranges from 0-70, with higher total scores indicating more impairment. A negative change score indicates improvement from baseline.
The overall clinical rating of change from baseline to week 24 measured by the 7-point CIBIC plus-J scale. The Clinician's Interview-Based Impression of Change plus Caregiver Input consists of 3 subscales: Disability Assessment of Dementia Scale, Behavioral Pathology in Alzheimer's Disease Rating Scale and Mental Function Impairment Scale, as well as the Clinician's Global Impression of Change (CGIC). Participants are scored according to the following: 1. Markedly improved 2. Moderately improved 3. Minimally improved 4. Unchanged 5. Minimally worse 6. Moderately worse 7. Markedly worse
| Arm | Type | Description |
|---|---|---|
| 1 step | EXPERIMENTAL | - |
| 3 step | ACTIVE_COMPARATOR | - |
| Rivastigmine patch | EXPERIMENTAL | Once-daily target patch size 10 cm² |
| Rivastigmine capsules | ACTIVE_COMPARATOR | Twice-daily target dose of 6 mg oral capsule |
| Rivastigmine capsule | EXPERIMENTAL | Rivastigmine capsules starting at a total dose of 3 mg/day (1.5 mg twice daily orally) titrated up in 3 mg/day increments every 4 weeks to a final dose of 12 mg/day (6 mg twice daily orally). The 12 mg/day dose or the highest dose tolerated was maintained until week 76. |
| Placebo | PLACEBO_COMPARATOR | Participants received daily matching placebo patch for the duration of the 24-week double-blind treatment phase of the study. |
| rivastigmine 5 cm^2 | EXPERIMENTAL | During the 16-week titration period patients received daily rivastigmine 2.5 cm\^2 patch for the first 4 weeks and thereafter daily rivastigmine 5 cm\^2 patch. For patients who experienced intolerability, the dose was adjusted to rivastigmine 2.5 cm\^2 daily. Patients then entered the 8-week maintenance period during which time they continued to receive the dose of rivastigmine they were taking at the end of the titration period. |
| Rivastigmine 10 cm^2 | EXPERIMENTAL | During the 16-week titration period patients received daily rivastigmine 2.5 cm\^2 patch for the first 4 weeks, rivastigmine 5 cm\^2 patch for the next 4 weeks, rivastigmine 7.5 cm\^2 patch for the next 4 weeks and then rivastigmine 10 cm\^2 patch for the final 4 weeks. For patients who experienced intolerability, the dose was adjusted downward. Patients then entered the 8-week maintenance period during which time they continued to receive the dose of rivastigmine they were taking at the end of the titration period. |
| Name | Type | Description |
|---|---|---|
| Active Comparator | DRUG | 1-step titration group begin treatment with a rivastigmine patch 9 mg/day for 4 weeks, followed by a dose increase to 18 mg/day. |
| ENA713 | DRUG | -3-step titration group will begin treatment with a rivastigmine patch 4.5 mg/day for 4 weeks, followed by a further dose increase of 4.5 mg/day at 4-week intervals up to the maintenance dose of 18 mg/day. |
| Rivastigmine Patch | DRUG | Once-daily target patch size 10 cm² |
| Rivastigmine Capsules | DRUG | Twice-daily target dose of 6 mg oral capsule |
| Placebo to Rivastigmine patch | DRUG | Matching placebo to Rivastigmine patch |
| Placebo to Rivastigmine capsules | DRUG | matching Placebo to Rivastigmine capsules |
| Rivastigmine capsule | DRUG | Rivastigmine capsules orally twice a day. Target dose 12 mg/day. |
| Rivastigmine transdermal patch | DRUG | Rivastigmine patch once a day in the morning, worn for 24 hours. Target dose 10 cm\^2/day delivering 9.5 mg over a 24 hour period. |
| Placebo | DRUG | Placebo transdermal patch was provided in the following sizes: 2.5 cm\^2, 5 cm\^2, 7.5 cm\^2 and 10 cm\^2. The caregiver applied one patch on the back of a patient, placed alternately from the right to the left side at approximately the same time each day. |
| Rivastigmine | DRUG | - |
Inclusion Criteria: * A diagnosis of dementia of the Alzheimer's type according to the DSM-IV criteria * A clinical diagnosis of probable AD according to NINCDS/ADRDA criteria * An MMSE score of ≥ 10 and ≤ 20 at baseline Exclusion Criteria: * Any medical or neurological conditions other than AD t...
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Rivastigmine is used to treat Alzheimer's disease, Parkinson's disease dementia, vascular dementia, and traumatic brain injury. It is a small molecule developed by Novartis AG under the ticker NVS. The drug is given as a capsule or a transdermal patch and has been studied in Phase 3 trials.
Rivastigmine targets both butyrylcholinesterase (BCHE) and acetylcholinesterase (ACHE). It acts as an inhibitor of these enzymes. By inhibiting ACHE and BCHE, rivastigmine increases acetylcholine levels in the brain, which is the intended mechanism in Alzheimer's disease and Parkinson's disease dementia.
Rivastigmine is developed by Novartis AG, which trades under the ticker NVS. Novartis is the company responsible for the drug's clinical development and regulatory submissions.
Rivastigmine is in Phase 3 development. Five Phase 3 trials have been completed, and no active trials are currently listed. The drug is investigational and has not been approved by the FDA for the indications studied.
Rivastigmine has been studied in five completed Phase 3 trials, including NCT01399125 in Alzheimer's disease in China, NCT00623103 in Parkinson's disease dementia across multiple countries, NCT00423085 in Alzheimer's disease in Japan, and NCT00219232, an open-label extension in probable Alzheimer's disease.
Yes, Rivastigmine Patch is an alternative name for Rivastigmine. Other names include Rivastigmine transdermal patch, Rivastigmine capsule, and Rivastigmine Transdermal Patch. These refer to the same active drug, which is available in both capsule and patch forms.