ADEPT

CompletedPhase 4Results posted

Clinical Effectiveness of 10 cm^2 Rivastigmine Patch in Patients With Alzheimer's Disease

A 24-week, Multi-center, Open, Evaluation of the Clinical Effectiveness of the Once-daily 10 cm^2 Rivastigmine Patch Formulation in Patients With Probable Alzheimer's Disease (MMSE10-26)

Lead sponsor

Novartis

Asset

Rivastigmine

Listed sites

Recruiting sites

Enrollment

208

actual

Study population

Alzheimer’s disease

Key I/E criterion

•Alzheimer's disease

Primary endpoints

•Percentage of Participants Treated by Rivastigmine 10 cm^2 Patch for at Least 8•Percentage of Participants Who Were Compliant to the 10 cm^2 Patch

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 IDCENA713DDE15

NCT IDNCT00561392

Timeline

Milestones

Study start2007-11 (month precision)

Study first posted2007-11-21estimated

Primary completion2008-11actual (month precision)

Study completion2008-11actual (month precision)

Results first posted2011-03-11estimated

Last update posted2012-04-16estimated

Assets

Drug assets

Rivastigmine

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age50 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Males, and females not of child-bearing potential (surgically sterile or at least one year postmenopausal), of at least 50 years of age

•Probable Alzheimer's disease according to the NINCDS-ADRDA (National Institute of Neurological and Communicative Diseases and Stroke/Alzheimer's Disease and Related Disorders Association) and DSM-IV (Diagnostic and Statistical Manual of Mental Disorders) criteria

•MMSE (Mini-Mental State Examination) score of > 10 and < 26

•Patients initiating therapy for the first time with a cholinesterase inhibitor (patients prescribed both rivastigmine and memantine are allowed)

•Patients who failed to benefit from previous cholinesterase inhibitor treatment

Exclusion criteria

•Patients not treated according to the product monograph for rivastigmine capsules

•patients involved in a clinical trial

•Current diagnosis of an active skin lesion/disorder that would prevent accurate assessment of the adhesion and potential skin irritation of the patch (e.g., atopic dermatitis, wounded or scratched skin in the area of the patch application)

Other protocol-defined exclusion criteria applied to the study.

Endpoints (18)

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

Caregiver / quality of life

Global cognition

Executive function / language

Function / daily living

Other clinical outcomes

Global cognition

2 endpoints

Secondary/protocol endpoint

Mean Change From Baseline in the Mini-Mental State Examination (MMSE) Score at Week 24

Time frame:Baseline and Week 24

Mini-Mental State Examination (MMSE)

change from baseline, improvement

Secondary/registry result

Mean Change From Baseline in the Mini-Mental State Examination (MMSE) Score at Week 24

Time frame:Baseline and Week 24

Mini-Mental State Examination (MMSE)

change from baseline, improvement

Posted result

Group	Value (mean), Units on a scale	Standard deviation
Rivastigmine 5 and 10 cm^2 Patchn=182 Participants	1.3	3.8

Executive function / language

2 endpoints

Secondary/protocol endpoint

Mean Change From Baseline in the Trail-making Test Part A Score at Week 24

Time frame:Baseline to Week 24

change from baseline, improvement

Secondary/registry result

Mean Change From Baseline in the Trail-making Test Part A Score at Week 24

Time frame:Baseline to Week 24

change from baseline, improvement

Posted result

Group	Value (mean), Seconds	Standard deviation
Rivastigmine 5 and 10 cm^2 Patchn=182 Participants	-8.9	109.45

Function / daily living

2 endpoints

Secondary/protocol endpoint

Mean Change From Baseline in the Alzheimer's Disease Cooperative Study-Activities of Daily Living (ADCS-ADL) Score at Week 24

Time frame:Baseline to Week 24

ADCS-Activities of Daily Living (ADCS-ADL)

change from baseline, improvement

Secondary/registry result

Mean Change From Baseline in the Alzheimer's Disease Cooperative Study-Activities of Daily Living (ADCS-ADL) Score at Week 24

Time frame:Baseline to Week 24

ADCS-Activities of Daily Living (ADCS-ADL)

change from baseline, improvement

Posted result

Group	Value (mean), Units on a scale	Standard deviation
Rivastigmine 5 and 10 cm^2 Patchn=182 Participants	1.3	12.02

Caregiver / quality of life

10 endpoints

Primary/protocol endpoint

Percentage of Participants Treated by Rivastigmine 10 cm^2 Patch for at Least 8 Weeks Who Completed the Study

Time frame:Baseline to Week 24

threshold achievement, improvement

Primary/protocol endpoint

Percentage of Participants Treated by Rivastigmine 10 cm^2 Patch for at Least 8 Weeks Regardless Whether They Completed the Study

Time frame:Baseline to Week 24

threshold achievement, improvement

Primary/protocol endpoint

Percentage of Participants Who Were Compliant to the 10 cm^2 Patch

Time frame:Baseline to Week 24

threshold achievement, improvement

Primary/registry result

Percentage of Participants Treated by Rivastigmine 10 cm^2 Patch for at Least 8 Weeks Who Completed the Study

Time frame:Baseline to Week 24

threshold achievement, improvement

Posted result

Group	Value (number), Percentage of participants	Reported bounds
Rivastigmine 5 and 10 cm^2 Patchn=182 Participants	74.2	-67.8 - 80.5

Primary/registry result

Percentage of Participants Treated by Rivastigmine 10 cm^2 Patch for at Least 8 Weeks Regardless Whether They Completed the Study

Time frame:Baseline to Week 24

threshold achievement, improvement

Posted result

Group	Value (number), Percentage of participants	Reported bounds
Rivastigmine 5 and 10 cm^2 Patchn=182 Participants	80.8	-75.0 - 86.5

Primary/registry result

Percentage of Participants Who Were Compliant to the 10 cm^2 Patch

Time frame:Baseline to Week 24

threshold achievement, improvement

Posted result

Group	Value (mean), Percentage of participants	Standard deviation
Rivastigmine 5 and 10 cm^2 Patchn=182 Participants	95.0	28.3

Secondary/protocol endpoint

Mean Change From Baseline in the Alzheimer's Disease Cooperative Study- Clinical Global Impression of Change (ADCS-CGIC) at Week 24 Assessed by the Caregiver

Time frame:Baseline t0 Week 24

change from baseline, improvement

Secondary/protocol endpoint

Mean Change From Baseline in the Mini-Zarit Inventory Score of Caregiver Burden at Week 24

Time frame:Baseline to Week 24

change from baseline, improvement

Secondary/registry result

Mean Change From Baseline in the Alzheimer's Disease Cooperative Study- Clinical Global Impression of Change (ADCS-CGIC) at Week 24 Assessed by the Caregiver

Time frame:Baseline t0 Week 24

change from baseline, improvement

Posted result

Group	Value (number), Participants	Reported bounds
Rivastigmine 5 and 10 cm^2 PatchNo changen=182 Participants	21	-
Minimal improvementn=182 Participants	23	-
Moderate improvementn=182 Participants	16	-
Marked improvementn=182 Participants	15	-
Minimal declinen=182 Participants	56	-
Moderate declinen=182 Participants	20	-
Marked declinen=182 Participants	14	-

Secondary/registry result

Mean Change From Baseline in the Mini-Zarit Inventory Score of Caregiver Burden at Week 24

Time frame:Baseline to Week 24

change from baseline, improvement

Posted result

Group	Value (mean), Units on a scale	Standard deviation
Rivastigmine 5 and 10 cm^2 Patchn=182 Participants	0.4	1.58

Other clinical outcomes

2 endpoints

Secondary/protocol endpoint

Change From Baseline in the Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change (ADCS-CGIC) at Week 24 Assessed by the Physician

Time frame:Baseline to Week 24

change from baseline, improvement

Secondary/registry result

Change From Baseline in the Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change (ADCS-CGIC) at Week 24 Assessed by the Physician

Time frame:Baseline to Week 24

change from baseline, improvement

Posted result

Group	Value (number), Participants	Reported bounds
Rivastigmine 5 and 10 cm^2 PatchNo changen=182 Participants	47	-
Minimal improvementn=182 Participants	25	-
Moderate improvementn=182 Participants	23	-
Marked improvementn=182 Participants	15	-
Minimal declinen=182 Participants	37	-
Moderate declinen=182 Participants	12	-
Marked declinen=182 Participants	5	-

Publications (1)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Articus K, Baier M, Tracik F, Kuhn F, Preuss UW, Kurz A. A 24-week, multicentre, open evaluation of the clinical effectiveness of the rivastigmine patch in patients with probable Alzheimer's disease. Int J Clin Pract. 2011 Jul;65(7):790-6. doi: 10.1111/j.1742-1241.2011.02713.x. Epub 2011 Jun 6.
PMID21645184via DERIVED

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.