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

NCT02703636 | Completed Phase 4 Results

• 1 other identifier: CENA713DJP02
• Study Type: interventional
• Target: 118
• Locations: 1 country
• Sites: 19

Brief 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).

Conditions

Mild to Moderate Alzheimer's Disease

Keywords

Alzheimer's disease

Outcome Measures

Primary Outcomes (1)

• 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

  baseline, weeks 8 and 24

Secondary Outcomes (7)

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

  baseline, weeks 8 and 24

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

  baseline and week 8

• Change in Neuropsychiatric Inventory - 10 Item (NPI-10) Score From Baseline to Week 8 and Week 24

  baseline, week 8, week 24

• Change in QOL-AD Score From Baseline to Week 24

  baseline and week 24

• Change in J-CGIC Score From Baseline and at Week 24

  baseline and week 24

Study Arms (1)

Rivastigmine Patch

OTHER

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.

Drug: Rivastigmine Patch

Interventions

Rivastigmine Patch DRUG

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.

Also known as: rivastigmine

Rivastigmine Patch

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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)
• 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.
• 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.
• 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
• Patients having difficulties being treated orally with ChEIs (donepezil or galantamine) by physician's judgement.
• Poor compliance or adverse event except GI symptoms
• Patients with swallowing difficulties.

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (19)

Novartis Investigative Site

Fukuoka, Fukuoka, 814 0180, Japan

Location

Novartis Investigative Site

Fukuoka, Fukuoka, 814-0015, Japan

Location

Novartis Investigative Site

Aizu-Wakamatsu, Fukushima, 965-8585, Japan

Location

Novartis Investigative Site

Tsukuba, Ibaraki, 305-8576, Japan

Location

Novartis Investigative Site

Kita-gun, Kagawa-ken, 761-0793, Japan

Location

Novartis Investigative Site

Sagamihara, Kanagawa, 252-5188, Japan

Location

Novartis Investigative Site

Kochi, Kochi, 780-0842, Japan

Location

Novartis Investigative Site

Sanjō, Niigata, 955-0823, Japan

Location

Novartis Investigative Site

Kurashiki, Okayama-ken, 710-0826, Japan

Location

Novartis Investigative Site

Osaka, Osaka, 543-8555, Japan

Location

Novartis Investigative Site

Suita, Osaka, 565 0871, Japan

Location

Novartis Investigative Site

Kasukabe, Saitama, 344-0036, Japan

Location

Novartis Investigative Site

Koshigaya, Saitama, 343-0032, Japan

Location

Novartis Investigative Site

Fuji, Shizuoka, 416-0955, Japan

Location

Novartis Investigative Site

Bunkyo Ku, Tokyo, 113-8431, Japan

Location

Novartis Investigative Site

Hachiōji, Tokyo, 193-0944, Japan

Location

Novartis Investigative Site

Shinjuku-ku, Tokyo, 160-0023, Japan

Location

Novartis Investigative Site

Suginami Ku, Tokyo, 168-8535, Japan

Location

Novartis Investigative Site

Okayama, 710-0813, Japan

Location

MeSH Terms

Conditions

Alzheimer Disease

Interventions

Rivastigmine

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Phenylcarbamates; Carbamates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals

Results Point of Contact

• Title: Study Director
• Organization: Novartis Pharmaceuticals

novartis.email@novartis.com

+1 (862) 778-8300

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2016
• First Posted: March 9, 2016
• Study Start: May 9, 2016
• Primary Completion: May 7, 2018
• Study Completion: May 7, 2018
• Last Updated: September 12, 2019
• Results First Posted: September 12, 2019

Record last verified: 2019-08

Locations

JP (19)