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CompletedPhase 3

An Open-label Extension to Evaluate the Efficacy and Safety of the Rivastigmine Transdermal Patch in Patients With Probable Alzheimer's Disease

Lead sponsor

Novartis

Asset

Rivastigmine

Listed sites

Recruiting sites

Enrollment

868

actual

Study population

Alzheimer’s disease

Key I/E criterion

•Age 50-85

Primary endpoint

•Safety and tolerability

Identifiers

Registered as

Org study IDCENA713D2320E1

NCT IDNCT00219232

Timeline

Milestones

Study start2003-02 (month precision)

Study first posted2005-09-22estimated

Primary completion2006-07actual (month precision)

Study completion2006-07actual (month precision)

Last update posted2017-02-23actual

Assets

Drug assets

Rivastigmine

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age50 Years

Maximum age85 Years

SexAll

Healthy volunteersNot accepted

Eligibility criteria

•Patients who fulfilled the inclusion and exclusion criteria as listed in the study CENA713D2320 and have completed the double-blind treatment phase on study medication without significant protocol violations.

Endpoints (6)

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

Other (unclassified)

Executive function / language

Function / daily living

Safety / tolerability / PK

Other clinical outcomes

Executive function / language

1 endpoint

Secondary/protocol endpoint

Change in executive function from baseline at week 52

change from baseline, improvement

Function / daily living

1 endpoint

Secondary/protocol endpoint

Change in activities of daily living from baseline at week 52

change from baseline, improvement

Safety / tolerability / PK

1 endpoint

Primary/protocol endpoint

Safety and tolerability as measured by adverse events, vital signs and skin irritation for up to 28 weeks treatment

event count, event

Other clinical outcomes

1 endpoint

Secondary/protocol endpoint

Clinical global impression of change from baseline at week 52

change from baseline, improvement

Other (unclassified)

2 endpoints

Secondary/protocol endpoint/low confidence

Change in cognition from baseline (week 24 of the double blind phase) at week 52

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change in behavioral symptoms from baseline at week 52

change from baseline, improvement

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

Grossberg G, Sadowsky C, Frostl H, Frolich L, Nagel J, Tekin S, Zechner S, Ros J, Orgogozo JM. Safety and tolerability of the rivastigmine patch: results of a 28-week open-label extension. Alzheimer Dis Assoc Disord. 2009 Apr-Jun;23(2):158-64. doi: 10.1097/wad.0b013e31818b1c2c.
PMID19484917via RESULT

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 21, 2026

Endpoint classificationDelfa ADRD endpoint taxonomy

Results tableno registry results posted yet

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.