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CompletedPhase 4

Safety and Tolerability of Rivastigmine With Add-on Memantine in Patients With Probable Alzheimer's Disease

A Prospective, 26-Week, Open-Label, Multi-Center, Single-Arm Pilot Study to Evaluate the Safety and Tolerability of Rivastigmine Capsule With Add on Memantine HCl in Patients With Probable Alzheimer's Disease (MMSE 10-20)

Lead sponsor

Novartis

Asset

Rivastigmine

Listed sites

1

Recruiting sites

-

Enrollment

150

estimated

Study population

Alzheimer’s disease

Key I/E criteria

•Alzheimer's disease•MMSE 10-20•Study partner/caregiver required

Primary endpoint

•Safety and tolerability of treatment with memantine and rivastigmine

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 IDCENA713BUS32
NCT IDNCT00305903

Timeline

Milestones

Study start2006-03 (month precision)
Study first posted2006-03-22estimated
Study completion2007-08actual (month precision)
Last update posted2007-12-21estimated

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

Inclusion criteria

•Have a diagnosis of probable Alzheimer's disease;
•Have an MMSE score between 10 and 20;
•Must be able to swallow capsule/tablet;
•Must have a caregiver who is able to attend all study visits

Exclusion criteria

•Have an advanced, severe, progressive, or unstable disease of any type that may interfere with efficacy and safety assessments or put the patient at special risk;
•Have a current diagnosis of active, uncontrolled seizure disorder;
•Have a history within the past year or current diagnosis of cerebrovascular disease
•Have a current diagnosis of severe or unstable cardiovascular disease;
•Had a myocardial infarction (MI) within the last six months;
•Have specific respiratory, digestive, renal, or endocrine disorders;
•Have had previous treatment with rivastigmine or memantine;

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

Safety / tolerability / PK
1
Other (unclassified)
1

Safety / tolerability / PK

1 endpoint
Primary/protocol endpoint

Safety and tolerability of treatment with memantine and rivastigmine, measured by the incidence of GI adverse events (nausea and vomiting)

event count, event

Other (unclassified)

1 endpoint
Secondary/protocol endpoint/low confidence

Whether patients on rivastigmine and memantine are able to reach and maintain higher doses of rivastigmine compared to historical data of rivastigmine monotherapy

descriptive

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.