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ENA1stepswitch

CompletedPhase 4Results posted

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

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)

Asset

Rivastigmine

Listed sites

19

Recruiting sites

-

Enrollment

118

actual

Study population

Alzheimer’s disease

Key I/E criteria

Alzheimer's diseaseMMSE 10-23

Primary endpoint

Mini-Mental State Examination (MMSE)

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

Org study IDCENA713DJP02
NCT IDNCT02703636

Timeline

Milestones

Study first posted2016-03-09estimated
Study start2016-05-09actual
Primary completion2018-05-07actual
Study completion2018-05-07actual
Last update posted2019-09-12actual
Results first posted2019-09-12actual

Assets

Drug assets

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age50 Years
Maximum age85 Years
SexAll
Healthy volunteersNot accepted

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.

Endpoints (16)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Global cognition
6
Behavior / neuropsychiatric
4
Caregiver / quality of life
4
Other clinical outcomes
2

Global cognition

6 endpoints
Primary/protocol endpoint

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

Time frame:baseline, weeks 8 and 24

Mini-Mental State Examination (MMSE)

change from baseline, improvement

Primary/registry result

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

Time frame:baseline, weeks 8 and 24

Mini-Mental State Examination (MMSE)

change from baseline, improvement

Posted result

GroupValue (mean), scores on a scaleStandard deviation
Rivastigmine Patchbaselinen=118 Participants17.333.80
change at week 8n=117 Participants0.292.17
change at week 24n=102 Participants-0.362.64
Mean Difference (Final Values)-0.3595% CI-0.87 - 0.16p0.1750t-test, 2 sided
Secondary/protocol endpoint

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

Time frame:baseline, weeks 8 and 24

Mini-Mental State Examination (MMSE)

change from baseline, improvement

Secondary/protocol endpoint

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

Time frame:baseline and week 8

Mini-Mental State Examination (MMSE)

change from baseline, improvement

Secondary/registry result

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

Time frame:baseline, weeks 8 and 24

Mini-Mental State Examination (MMSE)

change from baseline, improvement

Posted result

GroupValue (mean), scores on a scaleStandard deviation
Rivastigmine Patchbaselinen=112 Participants17.243.84
week 8n=112 Participants0.332.19
week 24n=98 Participants-0.322.63
Secondary/registry result

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

Time frame:baseline and week 8

Mini-Mental State Examination (MMSE)

change from baseline, improvement

Posted result

GroupValue (mean), scores on a scaleStandard deviation
Rivastigmine Patchbaselinen=114 Participants17.253.82
week 8n=114 Participants0.312.18

Behavior / neuropsychiatric

4 endpoints
Secondary/protocol endpoint

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

Time frame:baseline, week 8, week 24

Neuropsychiatric Inventory (NPI)

change from baseline, improvement

Secondary/protocol endpoint

Change in QOL-AD Score From Baseline to Week 24

Time frame:baseline and week 24

change from baseline, improvement

Secondary/registry result

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

Time frame:baseline, week 8, week 24

Neuropsychiatric Inventory (NPI)

change from baseline, improvement

Posted result

GroupValue (mean), scores on a scaleStandard deviation
Rivastigmine Patchbaselinen=118 Participants11.4311.15
week 8n=116 Participants-1.818.81
week 24n=102 Participants-0.8911.10
Secondary/registry result

Change in QOL-AD Score From Baseline to Week 24

Time frame:baseline and week 24

change from baseline, improvement

Posted result

GroupValue (mean), scores on a scaleStandard deviation
Rivastigmine Patchbaseline - Patient's assessmentn=118 Participants34.375.78
week 24 - Patient's assessmentn=102 Participants-0.345.32
baseline - Caregiver's assessmentn=118 Participants28.755.74
week 24 - Caregiver's assessmentn=103 Participants-0.165.42

Caregiver / quality of life

4 endpoints
Secondary/protocol endpoint

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

Time frame:baseline, weeks 4, 8, 16, 24

change from baseline, improvement

Secondary/protocol endpoint

Formulation Usability Questionnaire Form Score up to Week 24

Time frame:Up to week 24

descriptive

Secondary/registry result

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

Time frame:baseline, weeks 4, 8, 16, 24

change from baseline, improvement

Posted result

GroupValue (mean), scores on a scaleStandard deviation
Rivastigmine Patchbaselinen=118 Participants18.389.41
week 4n=117 Participants-0.415.44
week 8n=116 Participants-0.556.58
week 16n=108 Participants1.046.94
week 24n=103 Participants2.236.69
Secondary/registry result

Formulation Usability Questionnaire Form Score up to Week 24

Time frame:Up to week 24

descriptive

Posted result

GroupValue (count_of_participants), ParticipantsReported bounds
Rivastigmine PatchVery easy to usen=117 Participants38-
Easy to usen=117 Participants26-
No changen=117 Participants12-
Not easy to usen=117 Participants36-
Not easy to use at alln=117 Participants5-

Other clinical outcomes

2 endpoints
Secondary/protocol endpoint

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

Time frame:baseline and week 24

change from baseline, improvement

Secondary/registry result

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

Time frame:baseline and week 24

change from baseline, improvement

Posted result

GroupValue (count_of_participants), ParticipantsReported bounds
Rivastigmine PatchPatients without worsening, totaln=103 Participants91-
Patients with improvementn=103 Participants48-
Patients with worsening, totaln=103 Participants12-
Markedly improvedn=103 Participants3-
Improvedn=103 Participants6-
Slightly improvedn=103 Participants39-
No changen=103 Participants43-
Slightly aggravatedn=103 Participants11-
Aggravatedn=103 Participants1-
Markedly aggravatedn=103 Participants0-
Unassessablen=103 Participants0-

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 21, 2026
Endpoint classificationDelfa ADRD endpoint taxonomy
Results tableClinicalTrials.gov results section

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.