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Mild to Moderate Alzheimer's DiseasePhase 4ENA1stepswitchNCT02703636

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

A Phase 4 study testing Rivastigmine Patch in people with Mild to Moderate Alzheimer's Disease, run by Novartis Pharmaceuticals at 19 sites in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 50 to 85 years
Conditions the study is for
Mild to Moderate Alzheimer's Disease
What is being tested?
Rivastigmine Patch
Could I receive a placebo?
No, everyone receives an active treatment
How many people
118 participants
Where
19 sitesJapan
Study dates
9 May 2016to 7 May 2018
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
Show all 15Show fewer
  • 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.

Who cannot join

  • 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.
  • Other protocol-defined inclusion/exclusion criteria may apply.

Trial locations and contacts

19 sites in 1 country.

19 sites in 1 country

Japan19 sites

  • Novartis Investigative Site

    Aizu-Wakamatsu, Fukushima, 965-8585

  • Novartis Investigative Site

    Bunkyo Ku, Tokyo, 113-8431

  • Novartis Investigative Site

    Fuji, Shizuoka, 416-0955

  • Novartis Investigative Site

    Fukuoka, Fukuoka, 814 0180

  • Novartis Investigative Site

    Fukuoka, Fukuoka, 814-0015

  • Novartis Investigative Site

    Hachiōji, Tokyo, 193-0944

  • Novartis Investigative Site

    Kasukabe, Saitama, 344-0036

  • Novartis Investigative Site

    Kita-gun, Kagawa-ken, 761-0793

  • Novartis Investigative Site

    Kochi, Kochi, 780-0842

  • Novartis Investigative Site

    Koshigaya, Saitama, 343-0032

  • Novartis Investigative Site

    Kurashiki, Okayama-ken, 710-0826

  • Novartis Investigative Site

    Okayama, 710-0813

  • Novartis Investigative Site

    Osaka, Osaka, 543-8555

  • Novartis Investigative Site

    Sagamihara, Kanagawa, 252-5188

  • Novartis Investigative Site

    Sanjō, Niigata, 955-0823

  • Novartis Investigative Site

    Shinjuku-ku, Tokyo, 160-0023

  • Novartis Investigative Site

    Suginami Ku, Tokyo, 168-8535

  • Novartis Investigative Site

    Suita, Osaka, 565 0871

  • Novartis Investigative Site

    Tsukuba, Ibaraki, 305-8576

Other trials in Japan

About this study

Official title: A 24-week, Open-label, Multicenter Study to Evaluate the Efficacy, Safety and Tolerability of Rivastigmine Patch With 1-step Titration in Patients With Mild to Moderate Alzheimer's Disease (MMSE 10 - 23) Switched Directly From Holinesterase Inhibitors (Donepezil, Galantamine)

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).

Being tested
Rivastigmine Patch
Keywords
Alzheimer's disease
Medical subject headings
Alzheimer Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Rivastigmine PatchDrug

    Also called rivastigmine

    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.

Study groups in NCT02703636
Study groupRoleWhat they receive
Rivastigmine PatchOtherAlzheimer'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.
Receives: Drug: Rivastigmine Patch

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: baseline, weeks 8 and 24

Secondary outcomes (7)

  1. 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

    Measured: baseline, weeks 8 and 24

  2. 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

    Measured: baseline and week 8

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

    Evaluation of 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.

    Per protocol, Neuropsychiatric The NPI-10 total score is a sum of the 10 items, where the score for a domain is defined as the product of frequency (range: 1-4) and severity (range: 1-3). Each domain has a maximum score of 12 and all domains are equally weighted for the total score (thus the range for the total score is 0 to 120).

    A higher score indicates more severe impairment.

    Neuropsychiatry Inventory - 10 Minimum Score = 0 Maximum Score = 120

    Higher Score indicates worse outcome

    Measured: baseline, week 8, week 24

  4. Change in QOL-AD Score From Baseline to Week 24

    Evaluation of the efficacy of rivastigmine patch with 1-step titration measured as QOL-AD score at week 24.

    Unabbreviated Scale Name: Quality of Life - Alzheimer's Disease Minimum Score = 13 Maximum Score = 52

    Higher value indicates a better outcome

    QOL-AD is a 13-item questionnaire to assess the quality of life of Alzheimer's patients from the perspectives of patients and their caregivers. It covers several aspects, for example, the perception of health status, mood, functional capacity, personal relationships and leisure, financial situation, and life as a whole. Each item is quantified using a Likert scale with score one classified as poor, and score four as excellent where total scores range from 13 to 52. A lower score indicates more severe impairment.

    Measured: baseline and week 24

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

    Evaluation of the efficacy of rivastigmine patch with 1-step titration measured as the The Japanese-Clinical Global Impression of Change (J-CGIC) score at baseline and week 24

    J-CGIC is a 7-grade investigator's impression scale: 1. Markedly improved, 2. Improved, 3. Slightly improved, 4. No change, 5. Slightly aggravated, 6. Aggravated, 7. Markedly aggravated

    At week 24, 103 patients had available data

    Total score is in the 0 to 56 range. Higher score means more severe impairment.

    Unabbreviated scale title: Japanese -Cinical Global Impression of Change Minimum Score - 1 Maximum Score - 7

    Measured: baseline and week 24

  6. Change in as Modified Crichton Scale Score From Baseline to Week 4, 8, 16 and 24

    Evaluation of the efficacy of rivastigmine patch with 1-step titration measured as Modified Crichton Scale score week 4, week 8, week 16, and week 24.

    Modified Crichton Scale that assess basic activation of daily living, communication functions, and quality of life The following 7 items will be evaluated by caregiver. Total score is in the 0 to 56 range. Higher score means more severe impairment.

    Unabbreviated Scale Title: Modified Crichton scale Minimum score = 0 Maximum Score = 56 Higher score indicates worse outcome

    Measured: baseline, weeks 4, 8, 16, 24

  7. Formulation Usability Questionnaire Form Score up to Week 24

    Evaluation of the formulation usability of rivastigmine patch for up to 24 weeks as measured by the formulation usability questionnaire answered by caregiver.

    The Formulation usability preference questionnaire had been used to compare the previous oral AD drugs versus the patch The caregiver selects one of the following answers (1. Very easy to use, 2. Easy to use, 3. No change, 4. Not easy to use, 5. Not easy to use at all, 6. Unknown).

    This questionnaire data is used to assess if the usability of rivastigmine patch was preferred by the majority (> 50%) of AD patient caregivers or not.

    Unabbreviated Questionnaire title:

    Formulation Usability questionnaire Minimum Score = 1 Maximum Score = 6

    A higher score indicates its not easy to use and worse outcome.

    Measured: Up to week 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Mar 2016 (estimated)
  2. Study start9 May 2016
  3. Primary completion7 May 2018
  4. Study completion7 May 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
118 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02703636
Sponsor's protocol ID
CENA713DJP02
Acronym
ENA1stepswitch
Status last verified
Aug 2019
First submitted
26 Feb 2016
Last updated
12 Sep 2019
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: Novartis is committed to sharing access to patient-level data and supporting clinical documents from eligible studies with qualified external researchers. Requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to protect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Rivastigmine Patch in people with Mild to Moderate Alzheimer's Disease, run by Novartis Pharmaceuticals at 19 sites in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 19 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 12 Sep 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

MMSE Total Score: Change From Baseline to Week 8 and Week 24 (Full Analysis Set) (time frame: baseline, weeks 8 and 24). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02703636.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Sep 2019.

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