EXTRA

CompletedPhase 4Results posted

A 24 Week, Multicenter, Open, Evaluation of the Clinical Effectiveness of the Once-daily 10 cm^2 Rivastigmine Patch Formulation in Patients With Probable Alzheimer's Disease (EXTRA)

A 24 Week, Multicenter, Open, Evaluation of the Clinical Effectiveness of the Once-daily 10 cm2 Rivastigmine Patch Formulation in Patients With Probable Alzheimer's Disease (MMSE 10-26)

Lead sponsor

Novartis

Asset

Rivastigmine

Listed sites

Recruiting sites

Enrollment

228

actual

Study population

Alzheimer’s disease

Key I/E criteria

•Alzheimer's disease•MMSE 10-26•Study partner/caregiver required

Primary endpoint

•And Maintained the Maximum Dose of 10 cm^2 Rivastigmine Patch for at Least 8

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 IDCENA713DFR08

SecondaryN° EudraCT : 2007-003405-27

NCT IDNCT00622713

Timeline

Milestones

Study start2008-01 (month precision)

Study first posted2008-02-25estimated

Primary completion2009-01actual (month precision)

Study completion2009-01actual (month precision)

Last update posted2011-07-26estimated

Results first posted2011-07-26estimated

Assets

Drug assets

Rivastigmine

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age50 Years

SexAll

Inclusion criteria

•Males, and females of at least 50 years old with a primary caregiver

•Probable Alzheimer's disease

•Mini-Mental State Examination (MMSE) score of ≥ 10 and ≤ 26

•Patients initiating therapy for the first time with a Cholinesterase (ChE) inhibitor (patients prescribed both rivastigmine and memantine are allowed) or patients who failed to benefit from previous ChE inhibitor treatment

•Residing with someone in the community throughout the study or, if living alone, in contact with the responsible caregiver everyday

Exclusion criteria

•Patients not treated according to the product monograph for capsules

•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)

•History of allergy to topical products containing any of the constituents of the patches

Other protocol-defined inclusion/exclusion criteria may apply.

Endpoints (10)

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

Function / daily living

Caregiver / quality of life

Other clinical outcomes

Other (unclassified)

Global cognition

2 endpoints

Secondary/protocol endpoint

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

Time frame:Baseline to week 24

Mini-Mental State Examination (MMSE)

change from baseline, improvement

Secondary/registry result

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

Time frame:Baseline to week 24

Mini-Mental State Examination (MMSE)

change from baseline, improvement

Posted result

Group	Value (mean), scores on a scale	Standard deviation
Rivastigmine Transdermal PatchBaseline (n = 216)n=218 Participants	19.2	4.11
Week 24 (n = 203)n=218 Participants	19.2	5.19
Change from baseline to week 24 (n = 203)n=218 Participants	0.0	3.18

Function / daily living

2 endpoints

Secondary/protocol endpoint

Mean Change From Baseline to Week 24 in the 4-item Instrumental Activities of Daily Living (4-IADL) Score

Time frame:Baseline to week 24

change from baseline, improvement

Secondary/registry result

Mean Change From Baseline to Week 24 in the 4-item Instrumental Activities of Daily Living (4-IADL) Score

Time frame:Baseline to week 24

change from baseline, improvement

Posted result

Group	Value (mean), scores on a scale	Standard deviation
Rivastigmine Transdermal PatchBaseline (n= 198)n=218 Participants	3.2	1.18
Week 24 (n= 181)n=218 Participants	3.2	1.16
Change from Baseline to week 24 (n= 172)n=218 Participants	0.1	0.74

Caregiver / quality of life

2 endpoints

Secondary/protocol endpoint

Mean Change From Baseline to Week 24 in the Mini-Zarit Inventory Score

Time frame:Baseline to week 24

change from baseline, improvement

Secondary/registry result

Mean Change From Baseline to Week 24 in the Mini-Zarit Inventory Score

Time frame:Baseline to week 24

change from baseline, improvement

Posted result

Group	Value (mean), Scores on a scale	Standard deviation
Rivastigmine Transdermal PatchBaseline (n= 211)n=218 Participants	2.8	1.76
Week 24 (n= 199)n=218 Participants	2.9	1.85
Change from baseline to week 24 (n= 197)n=218 Participants	0.1	1.35

Other clinical outcomes

2 endpoints

Secondary/protocol endpoint

Clinical Global Impression of Change (CGI-C) by Physician

Time frame:Baseline and week 24

descriptive

Secondary/registry result

Clinical Global Impression of Change (CGI-C) by Physician

Time frame:Baseline and week 24

descriptive

Posted result

Group	Value (number), Percentage of participants	Reported spread
Rivastigmine Transdermal PatchVery much improvedn=208 Participants	4.3	5.2
Much improvedn=208 Participants	13.0	-
Slightly improvedn=208 Participants	23.1	-
Unchangedn=208 Participants	32.2	-
Slightly worsenedn=208 Participants	19.2	-
Much worsenedn=208 Participants	5.8	-
Very much worsenedn=208 Participants	2.4	-

Other (unclassified)

2 endpoints

Primary/protocol endpoint/low confidence

Percentage of Patients Who Achieved and Maintained the Maximum Dose of 10 cm^2 Rivastigmine Patch for at Least 8 Weeks During 24 Weeks Study

Time frame:24 weeks

threshold achievement, improvement

Primary/registry result/low confidence

Percentage of Patients Who Achieved and Maintained the Maximum Dose of 10 cm^2 Rivastigmine Patch for at Least 8 Weeks During 24 Weeks Study

Time frame:24 weeks

threshold achievement, improvement

Posted result

Group	Value (number), Percentage of participants	Reported bounds
Rivastigmine Transdermal Patchn=218 Participants	70.6	-

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.