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EXPECT

CompletedPhase 4

Exelon Patch and Combination With Memantine Comparative Trial

A Multicenter, Randomized, Open-label Study to Compare the Tolerability Between Rivastigmine Patch Monotherapy and Combination Therapy With Memantine in Patients With Alzheimer's Disease

Asset

Rivastigmine

Listed sites

26

Recruiting sites

-

Enrollment

206

actual

Study population

Alzheimer’s disease

Key I/E criteria

•Alzheimer's disease•MMSE 10-20

Primary endpoint

•Retention rate

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 IDEXPECT
NCT IDNCT01025466

Timeline

Milestones

Study start2008-12 (month precision)
Primary completion2009-11actual (month precision)
Study first posted2009-12-03estimated
Study completion2010-04actual (month precision)
Last update posted2010-05-19estimated

Assets

Drug assets

Rivastigmine

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age50 Years
Maximum age90 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

•Dementia by DSM-IV and probable AD by NINCDS-ADRDA
•Age of 50 to 90 years
•Mini-Mental State Examination (MMSE) score of 10 to 20
•Brain MRI or CT scan consistent with a diagnosis of probable AD
•The caregiver must meet the patient at least once a week and be sufficiently familiar with the patient to provide accurate data.
•Ambulatory or ambulatory-aided (is, walker or cane) ability
•Written informed consent will be obtained from the patient (if possible) and from the patient's legally acceptable representative. Even if unable to provide written informed consent, the patient must assent verbally to participating in the study

Exclusion criteria

•Patients with evidence of severe or unstable physical illness, i.e., acute and severe asthmatic conditions, severe or unstable cardiovascular disease, active peptic ulcer disease, severe hepatic or renal disease, or any medical condition which would prohibit them from completing the study
•Any psychiatric or primary neurodegenerative disorder other than AD
•Any patients with hearing or visual problem that can disturb the efficient evaluation of the patients.
•Any patients with a history of drug addiction or alcohol addiction for the past 10 years
•Patients with bradycardia (bpm less than 50) or sick sinus syndrome or conduction defects (sino-atrial block, second ot third degree A-V blocks
•Clinically significant laboratory abnormalities to affect cognitive function (i.e.abnormal thyroid function test, abnormal low level of vitamin B12 or folate, or syphilis, etc)
•History of allergy to topical products containing any of the constitution of the patches
•Current diagnosis of an active skin lesion
•Involved in other clinical trials or treated by experimental drug within 4 weeks
•Patients with hypersensitivity to cholinesterase inhibitors

Endpoints (9)

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
2
Behavior / neuropsychiatric
2
Executive function / language
1
Function / daily living
1
Safety / tolerability / PK
1
Other clinical outcomes
1
Other (unclassified)
1

Global cognition

2 endpoints
Secondary/protocol endpoint

Change from baseline at week 16 in Mini-Mental State Examination

Time frame:16 weeks after randomization

Mini-Mental State Examination (MMSE)

change from baseline, improvement

Secondary/protocol endpoint

Change from baseline at week 16 in Clinical Dementia Rating Scale-Sum of Boxes

Time frame:16 weeks after randomization

Clinical Dementia Rating-Sum of Boxes (CDR-SB)

change from baseline, improvement

Executive function / language

1 endpoint
Secondary/protocol endpoint

Change from baseline at week 16 in Frontal Assessment Battery

Time frame:16 weeks after randomization

change from baseline, improvement

Function / daily living

1 endpoint
Secondary/protocol endpoint

Change from baseline at week 16 in Alzheimer's Disease Cooperative Study - Activities of Daily Living

Time frame:16 weeks after randomization

change from baseline, improvement

Behavior / neuropsychiatric

2 endpoints
Secondary/protocol endpoint

Change from baseline at week 16 in Caregiver-Administered Neuropsychiatric Inventory

Time frame:16 weeks after randomization

Neuropsychiatric Inventory (NPI)

change from baseline, improvement

Secondary/protocol endpoint

Change from baseline at week 16 in Cohen Mansfield Agitation Inventory

Time frame:16 weeks after randomization

change from baseline, improvement

Safety / tolerability / PK

1 endpoint
Secondary/protocol endpoint

Safety

Time frame:from baseline to end-point

descriptive

Other clinical outcomes

1 endpoint
Primary/protocol endpoint

Retention rate at week 16 after randomization

Time frame:End point (16 weeks after randomization)

descriptive

Other (unclassified)

1 endpoint
Secondary/protocol endpoint/low confidence

Change from baseline at week 16 in Alzheimer's Disease Assessment Scale-Cognitive subscale

Time frame:16 weeks after randomization

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

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.