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Trial record 6 of 2289 for:    alzheimer disease

Study to Evaluate the Efficacy, Safety and Tolerability of Rivastigmine Patch in Patients With Mild to Moderate Alzheimer's Disease (ENA1stepswitch)

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ClinicalTrials.gov Identifier: NCT02703636
Recruitment Status : Recruiting
First Posted : March 9, 2016
Last Update Posted : June 21, 2017
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

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).

Condition or disease Intervention/treatment Phase
Mild to Moderate Alzheimer's Disease Drug: Rivastigmine Patch Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A 24-week, Open-label, Multicenter Study to Evaluate the Efficacy, Safety and Tolerability of Rivastigmine Patchwith 1-step Titration in Patients With Mild to Moderate Alzheimer's Disease (MMSE 10 - 23) Switched Directly From Cholinesterase Inhibitors (Donepezil, Galantamine)
Actual Study Start Date : May 10, 2016
Estimated Primary Completion Date : April 24, 2018
Estimated Study Completion Date : April 24, 2018


Arm Intervention/treatment
Rivastigmine Patch
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
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.
Other Name: rivastigmine



Primary Outcome Measures :
  1. Change from baseline to week 24 in the total score of Mini-Mental State Examination (MMSE) [ Time Frame: Up to week 24 ]
    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 MMSE in mild to moderate Alzheimer's disease (AD) patients who failed to benefit from other cholinesterase inhibitors (ChEIs)


Secondary Outcome Measures :
  1. Monitoring and recording of all adverse events (AEs) and serious adverse events (SAEs). [ Time Frame: Up to week 24 ]
    To evaluate the safety, tolerability of rivastigmine patch with 1-step titration for up to 24 weeks.

  2. Change from baseline to Week 8 in Mini-Mental State Examination (MMSE) total score. [ Time Frame: week 8 ]
    To evaluate the efficacy of rivastigmine patch with 1-step titration measured as the MMSE score at week 8.

  3. Change in Neuropsychiatric Inventory - 10 Item (NPI-10) score from baseline to week 8 and week 24 [ Time Frame: week 8, week 24 ]
    To evaluate the efficacy of rivastigmine patch with 1-step titration measured as the Neuropsychiatric Inventory - 10 Item (NPI-10)score at week 8 and week 24.

  4. Change in QOL-AD score from baseline to week 24 [ Time Frame: Week 24 ]
    To evaluate the efficacy of rivastigmine patch with 1-step titration measured as QOL-AD score at week 24.

  5. Change in J-CGIC score from baseline to week 4, 8, 16 and 24 [ Time Frame: week 4, 8, 16, 24 ]
    To evaluate the efficacy of rivastigmine patch with 1-step titration measured as the J-CGIC score at week 4, week 8, week 16 and week 24

  6. Change in as Modified Crichton Scale score from baseline to week 4, 8, 16 and 24 [ Time Frame: week 4, 8, 16, 24 ]
    To evaluate the efficacy of rivastigmine patch with 1-step titration measured as Modified Crichton Scale score week 4, week 8, week 16, and week 24.

  7. Formulation usability score up to week 24 [ Time Frame: Upto week 24 ]
    To evaluate the formulation usability of rivastigmine patch for up to 24 weeks as measured by the formulation usability questionnaire answered by caregiver.



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Ages Eligible for Study:   50 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02703636


Contacts
Contact: Novartis Pharmaceuticals +81337978748
Contact: Novartis Pharmaceuticals

Locations
Japan
Novartis Investigative Site Recruiting
Fukuoka-city, Fukuoka, Japan, 814-001
Novartis Investigative Site Recruiting
Fukuoka-city, Fukuoka, Japan, 814-0180
Novartis Investigative Site Recruiting
Aizuwakamatsu, Fukushima, Japan, 965-8585
Novartis Investigative Site Recruiting
Tsukuba-city, Ibaraki, Japan, 305-8576
Novartis Investigative Site Recruiting
Kita-gun, Kagawa, Japan, 761-0793
Novartis Investigative Site Recruiting
Sagamihara-city, Kanagawa, Japan, 252-5188
Novartis Investigative Site Recruiting
Kochi-city, Kochi, Japan, 780-0842
Novartis Investigative Site Recruiting
Kurashiki-city, Okayama, Japan, 710-0826
Novartis Investigative Site Recruiting
Osaka-city, Osaka, Japan, 543-8555
Novartis Investigative Site Recruiting
Suita-city, Osaka, Japan, 565-0871
Novartis Investigative Site Recruiting
Kasukabe-city, Saitama, Japan, 344-0036
Novartis Investigative Site Recruiting
Koshigaya-city, Saitama, Japan, 343-0032
Novartis Investigative Site Recruiting
Fuji-city, Shizuoka, Japan
Novartis Investigative Site Recruiting
Izunokuni, Shizuoka, Japan, 410-2295
Novartis Investigative Site Recruiting
Bunkyo-ku, Tokyo, Japan, 113-8431
Novartis Investigative Site Recruiting
Hachioji-city, Tokyo, Japan, 193-0944
Novartis Investigative Site Recruiting
Niigata, Japan
Novartis Investigative Site Recruiting
Okayama, Japan, 710-0813
Novartis Investigative Site Recruiting
Shinjuku-ku, Japan, 160-0023
Novartis Investigative Site Recruiting
Tokyo, Japan, 168-8535
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals

Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02703636     History of Changes
Other Study ID Numbers: CENA713DJP02
First Posted: March 9, 2016    Key Record Dates
Last Update Posted: June 21, 2017
Last Verified: June 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Alzheimer's disease

Additional relevant MeSH terms:
Alzheimer Disease
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Dementia
Tauopathies
Rivastigmine
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Neuroprotective Agents
Protective Agents