NextStep:Study to Evaluate Safety,Efficacy & Tolerability of Rivastigmine Patch in Mild to Moderate Alzheimer's Patients.
Condition: Mild to Moderate Alzheimer's Disease
MeSH terms: Alzheimer Disease
Intervention: Rivastigmine Patch
Intervention description: Alzheimer's disease patient who is applicable to 1 step titration method (initial loading dose is a rivastigmine patch 9.0 mg/day and will be up-titrated after 4 weeks to reach the maintenance dose of 18 mg/day). Rivastigmine patch is a marketed drug, therefore the dose, dose regimen and titration scheme are in accordance with product label.
Intervention MeSH terms: Rivastigmine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 118.0
Sex: All
Minimum age: 50 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: Alzheimer's disease

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).
    

Eligibility criteria:

        Inclusion Criteria:

          1. Outpatient status at baseline.

          2. Males, and females not of child-bearing potential (surgically sterile, or one year or
             more from last menses).

          3. A diagnosis of dementia of the Alzheimer's type according to the DSM-IV criteria.

          4. 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.

          5. Brain scan (magnetic resonance imaging [MRI], or computed tomography [CT]) were met
             diagnosis criteria conducted within 3 years prior to baseline.

          6. 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.

          7. MMSE score of ≥ 10 and ≤ 23 at screening and baseline.

          8. Patients are currently on the oral monotherapy (donepezil, 5 mg), or galantamine
             (16-24 mg) for 4 weeks prior to baseline visit.

          9. Patients who failed to receive enough treatment benefit from the previous treatment
             can be defined if the patients meet at least one of following conditions at screening
             and baseline (multiple choices allowed)

         10. Patients who declined ≥ 2 points of MMSE despite of treatment of other oral
             Cholinesterase (ChE) inhibitors within initial 3-month and continued to show
             insufficient treatment effect until at baseline.

         11. During 6 months prior to screening visit, patients who declined ≥2 points of MMSE with
             other oral ChE inhibitors and continued to show insufficient treatment effect until at
             baseline.

         12. Patients who show marked worsening of BPSD, or ADL (can be defined by 1 state
             progression of FAST) judged by a physician despite of treatment of other oral ChE
             inhibitors in initial 3-month or last 6-month with other oral ChE inhibitors

         13. Patients having difficulties being treated orally with ChEIs (donepezil or
             galantamine) by physician's judgement.

         14. Poor compliance or adverse event except GI symptoms

         15. Patients with swallowing difficulties.

        Exclusion Criteria:

          1. 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

          2. 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

          3. 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

          4. Current diagnosis of an active skin lesion/disorder

          5. Patients with a history of hypersensitivity to any ingredients of rivastigmine or
             carbamate derivatives

          6. 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.

        Other protocol-defined inclusion/exclusion criteria may apply.