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Rivastigmine Patch · 4 trials · 2 indications
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 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 |
|---|---|---|
| Rivastigmine patch | EXPERIMENTAL | Once-daily target patch size 10 cm² |
| Rivastigmine capsules | ACTIVE_COMPARATOR | Twice-daily target dose of 6 mg oral capsule |
| 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 |
|---|---|---|
| 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 transdermal patch | DRUG | Rivastigmine transdermal patch was provided in the following sizes and doses: 2.5 cm\^2 (4.5 mg), 5 cm\^2 (9 mg), 7.5 cm\^2 (13.5 mg), and 10 cm\^2 (18 mg). 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. |
| 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. |
Inclusion criteria: * have a diagnosis of dementia of the Alzheimer's type according to the Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV) criteria; * have a clinical diagnosis of probable AD according to NINCDS/ADRDA criteria. * have a brain scan (magnetic resonance im...
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Rivastigmine is an investigational small molecule in Phase 3 clinical development for neurological conditions including Alzheimer's Disease, Vascular Dementia, Parkinson's Disease Dementia, and Traumatic Brain Injury. It is being studied for its effects on cognitive disorders associated with these conditions.
Rivastigmine is being developed by Novartis AG, a multinational pharmaceutical company traded on the New York Stock Exchange under the ticker symbol NVS. The company is conducting Phase 3 clinical trials to evaluate the drug's safety and efficacy in various dementia and cognitive impairment indications.
Rivastigmine is in Phase 3 clinical development. It has completed four Phase 3 trials, with no active trials currently ongoing. The drug remains investigational and has not been reported as approved by regulatory authorities for the studied indications.
Rivastigmine has completed four Phase 3 clinical trials: NCT00000174 in Alzheimer's Disease, NCT00130338 in Vascular Dementia, NCT00171795 in Traumatic Brain Injury, and NCT00623103 in Parkinson's Disease Dementia. These trials were completed with a total enrollment of approximately 3,268 participants across multiple countries.
Rivastigmine is the generic name for the drug marketed under the brand name Exelon. Clinical trial NCT00000174, titled 'Investigation Into Delay to Diagnosis of Alzheimer's Disease With Exelon (InDDEx)', uses the brand name Exelon to refer to the same drug substance.