NextStep:Study to Evaluate Safety,Efficacy & Tolerability of Rivastigmine Patch in Mild to Moderate Alzheimer's Patients.

Novartis Pharmaceuticals118 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

118

Conditions

Mild to Moderate Alzheimer's Disease

Interventions

Rivastigmine PatchDRUG

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.

Eligibility

Sex: ALLMin age: 50 YearsMax age: 85 Years

Medical Language ↔ Plain English

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.

Locations (19)

Novartis Investigative Site

Fukuoka, Fukuoka, Japan

Novartis Investigative Site

Fukuoka, Fukuoka, Japan

Outcomes

Primary Outcomes

MMSE Total Score: Change From Baseline to Week 8 and Week 24 (Full Analysis Set)

Evaluation of 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 MMSE in mild to moderate Alzheimer's disease (AD) patients who failed to benefit from other cholinesterase inhibitors (ChEIs) The MMSE is a screening test for cognitive dysfunction. The test consists of five sections (orientation, registration, attention-calculation, recall, and language); the total score can range from 0 to 30, with a higher score indicating better function. A positive change score indicates improvement from baseline. Abbreviated Scale title: Mini Mental State Evaluation Minimum Score: 0 Maximum score: 30 Higher score indicated better cognitive function

Time frame: baseline, weeks 8 and 24

Secondary Outcomes

MMSE Total Score: Change From Baseline to Week 8 and Week 24

Evaluation of the safety, tolerability of rivastigmine patch with 1-step titration for up to 24 weeks. Per Protocol, The MMSE is a brief, practical screening test for cognitive dysfunction. The MMSE consists of 2 parts: language (time orientation, registration and attention) and performance (recall, response to written/verbal commands, writing ability and reproduction of complex polygons), and the total possible score is 30. Lower score indicates more severe impairment. It is the most common and simple cognitive scale for Alzheimer's disease. Unabbreviated Scale : MMSE - Mini Mental State Evaluation: Minimum values - 0 Maximum value - 30 Higher Value means a better outcome Positive change score from baseline indicates improvement in cognitive function

Time frame: baseline, weeks 8 and 24

Change From Baseline to Week 8 in Mini-Mental State Examination (MMSE) Total Score

Evaluation of the efficacy of rivastigmine patch with 1-step titration measured as the MMSE score at week 8 for patients who had 1-step titration MMSE total score: change from baseline to Week 8 and Week 24 for patients who had 1-step titration Unabbreviated Scale : MMSE - Mini Mental State Evaluation: Minimum values - 0 Maximum value - 30 Higher Value means a better outcome Positive change score from baseline indicates better outcome

Data from ClinicalTrials.gov

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