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ENA1stepswitch
CompletedPhase 4Results postedNextStep: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)
Lead sponsor
Asset
Rivastigmine
Listed sites
19
Recruiting sites
-
Enrollment
118
actual
Study population
Alzheimer’s disease
Key I/E criteria
•Alzheimer's disease•MMSE 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
Timeline
Milestones
Assets
Drug assets
Study populations
Who this study enrolls
Eligibility
Who can enroll
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 endpointsMMSE 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
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
| Group | Value (mean), scores on a scale | Standard deviation |
|---|---|---|
| Rivastigmine Patchbaselinen=118 Participants | 17.33 | 3.80 |
| change at week 8n=117 Participants | 0.29 | 2.17 |
| change at week 24n=102 Participants | -0.36 | 2.64 |
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
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
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
| Group | Value (mean), scores on a scale | Standard deviation |
|---|---|---|
| Rivastigmine Patchbaselinen=112 Participants | 17.24 | 3.84 |
| week 8n=112 Participants | 0.33 | 2.19 |
| week 24n=98 Participants | -0.32 | 2.63 |
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
| Group | Value (mean), scores on a scale | Standard deviation |
|---|---|---|
| Rivastigmine Patchbaselinen=114 Participants | 17.25 | 3.82 |
| week 8n=114 Participants | 0.31 | 2.18 |
Behavior / neuropsychiatric
4 endpointsChange 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
Change in QOL-AD Score From Baseline to Week 24
Time frame:baseline and week 24
change from baseline, improvement
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
| Group | Value (mean), scores on a scale | Standard deviation |
|---|---|---|
| Rivastigmine Patchbaselinen=118 Participants | 11.43 | 11.15 |
| week 8n=116 Participants | -1.81 | 8.81 |
| week 24n=102 Participants | -0.89 | 11.10 |
Change in QOL-AD Score From Baseline to Week 24
Time frame:baseline and week 24
change from baseline, improvement
Posted result
| Group | Value (mean), scores on a scale | Standard deviation |
|---|---|---|
| Rivastigmine Patchbaseline - Patient's assessmentn=118 Participants | 34.37 | 5.78 |
| week 24 - Patient's assessmentn=102 Participants | -0.34 | 5.32 |
| baseline - Caregiver's assessmentn=118 Participants | 28.75 | 5.74 |
| week 24 - Caregiver's assessmentn=103 Participants | -0.16 | 5.42 |
Caregiver / quality of life
4 endpointsChange 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
Formulation Usability Questionnaire Form Score up to Week 24
Time frame:Up to week 24
descriptive
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
| Group | Value (mean), scores on a scale | Standard deviation |
|---|---|---|
| Rivastigmine Patchbaselinen=118 Participants | 18.38 | 9.41 |
| week 4n=117 Participants | -0.41 | 5.44 |
| week 8n=116 Participants | -0.55 | 6.58 |
| week 16n=108 Participants | 1.04 | 6.94 |
| week 24n=103 Participants | 2.23 | 6.69 |
Formulation Usability Questionnaire Form Score up to Week 24
Time frame:Up to week 24
descriptive
Posted result
| Group | Value (count_of_participants), Participants | Reported bounds |
|---|---|---|
| Rivastigmine PatchVery easy to usen=117 Participants | 38 | - |
| Easy to usen=117 Participants | 26 | - |
| No changen=117 Participants | 12 | - |
| Not easy to usen=117 Participants | 36 | - |
| Not easy to use at alln=117 Participants | 5 | - |
Other clinical outcomes
2 endpointsChange in J-CGIC Score From Baseline and at Week 24
Time frame:baseline and week 24
change from baseline, improvement
Change in J-CGIC Score From Baseline and at Week 24
Time frame:baseline and week 24
change from baseline, improvement
Posted result
| Group | Value (count_of_participants), Participants | Reported bounds |
|---|---|---|
| Rivastigmine PatchPatients without worsening, totaln=103 Participants | 91 | - |
| Patients with improvementn=103 Participants | 48 | - |
| Patients with worsening, totaln=103 Participants | 12 | - |
| Markedly improvedn=103 Participants | 3 | - |
| Improvedn=103 Participants | 6 | - |
| Slightly improvedn=103 Participants | 39 | - |
| No changen=103 Participants | 43 | - |
| Slightly aggravatedn=103 Participants | 11 | - |
| Aggravatedn=103 Participants | 1 | - |
| Markedly aggravatedn=103 Participants | 0 | - |
| Unassessablen=103 Participants | 0 | - |
Provenance
Sources
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.