← Trials/Trial dossier/NCT01047579

BETTER

CompletedPhase 4

A 12 Week, Multicenter, Open Label Evaluation of Caregiver Preference, Safety and Tolerability of Exelon® Patch (Rivastigmine Transdermal) in Patients With Alzheimer's Disease

Lead sponsor

Novartis Pharmaceuticals

Asset

Rivastigmine

Listed sites

Recruiting sites

Enrollment

actual

Study population

Alzheimer’s disease

Key I/E criteria

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

Primary endpoint

•Caregiver questionnaire

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 IDCENA713DIL01

NCT IDNCT01047579

Timeline

Milestones

Study first posted2010-01-13estimated

Study start2010-04 (month precision)

Primary completion2012-01actual (month precision)

Study completion2012-01actual (month precision)

Last update posted2017-02-24actual

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

•Probable Alzheimer's disease according to the NINCDS-ADRDA and DSM-IV criteria.

•MMSE score of >10 and <26.

•Patients who were under ChE inhibitor treatment and experienced adverse events.

•Residing with someone in the communities throughout the study or if, living alone, in contact with the responsible caregiver every day, primary caregiver willing to accept responsibility for supervising the treatment and condition of the patient

Exclusion criteria

•Involved in other clinical trials or treated by experimental drug within the previous 4 weeks.

•Current diagnosis of an active skin lesion that would prevent accurate assessment of the adhesion and potential skin irritation of the patch.

•History of allergy to topical products containing any of the constitution of the patches.

•Patients with evidence of severe or unstable physical illness, i.e., acute and severe asthmatic conditions, severe or unstable cardiovascular disorders, etc.

•Patients with bradycardia (bpm less than 50) or sick sinus syndrome or conduction defects (sino-atrial block, second degree A-V blocks).

•Patients with body weight less than 40 kg.

Other protocol-defined inclusion/exclusion criteria may apply

Endpoints (2)

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

Safety / tolerability / PK

Caregiver / quality of life

1 endpoint

Primary/protocol endpoint

Caregiver questionnaire

Time frame:12 weeks

descriptive

Safety / tolerability / PK

1 endpoint

Secondary/protocol endpoint

Safety and Tolerability. Safety assessments include vital signs and adverse events (AEs)

Time frame:every visit

event count, event

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.