NextStep:Study to Evaluate Safety,Efficacy & Tolerability of Rivastigmine Patch in Mild to Modera… (NCT02703636) | Clinical Trial Compass
CompletedPhase 4
NextStep:Study to Evaluate Safety,Efficacy & Tolerability of Rivastigmine Patch in Mild to Moderate Alzheimer's Patients.
Japan118 participantsStarted 2016-05-09
Plain-language summary
To evaluate the efficacy of rivastigmine patch with 1-step titration on cognitive function measured as change from baseline to week 24 in the total score of Mini-Mental State Examination (MMSE) in mild to moderate Alzheimer's disease (AD) patients who failed to benefit from other cholinesterase inhibitors (ChEIs).
Who can participate
Age range50 Years – 85 Years
SexALL
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Inclusion criteria
✓. Outpatient status at baseline.
✓. Males, and females not of child-bearing potential (surgically sterile, or one year or more from last menses).
✓. A diagnosis of dementia of the Alzheimer's type according to the DSM-IV criteria.
✓. A clinical diagnosis of probable AD according to National Institute of Neurological and Communicative Disorders and Stroke - Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria.
✓. Brain scan (magnetic resonance imaging \[MRI\], or computed tomography \[CT\]) were met diagnosis criteria conducted within 3 years prior to baseline.
✓. Positron emission tomography (PET) or single photon emission computed tomography (SPECT) was met diagnosis criteria conducted within 3 years prior to baseline visit, as long as in the past a brain scan (MRI or CT) also was met.
✓. MMSE score of ≥ 10 and ≤ 23 at screening and baseline.
✓. Patients are currently on the oral monotherapy (donepezil, 5 mg), or galantamine (16-24 mg) for 4 weeks prior to baseline visit.
Exclusion criteria
✕. Any medical or neurological condition other than AD that could explain the patient's dementia (e.g., abnormal thyroid function tests, vitamin B12 or folate deficiency, posttraumatic conditions, syphilis, head injury, Huntington's disease, Parkinson's disease, subdural hematoma, normal pressure hydrocephalus, brain tumor) at baseline
✕. Any other DSM-IV Axis 1 diagnosis that may interfere with the evaluation of the patient's response to study medication, including other primary neurodegenerative dementia, schizophrenia, or bipolar disorder
What they're measuring
1
MMSE Total Score: Change From Baseline to Week 8 and Week 24 (Full Analysis Set)
✕. An advanced, severe, progressive, or unstable disease of any type that may interfere with efficacy and safety assessments or put the patient at special risk
✕. Current diagnosis of an active skin lesion/disorder
✕. Patients with a history of hypersensitivity to any ingredients of rivastigmine or carbamate derivatives
✕. Each patient will be required to have a primary caregiver willing to accept responsibility for supervising treatment, assessing the patient's condition throughout the study, and for providing input into efficacy assessments.