CompletedPhase 4

Rivastigmine Monotherapy and Combination Therapy With Memantine in Patients With Moderately Severe Alzheimer's Disease Who Failed to Benefit From Previous Cholinesterase Inhibitor Treatment

An Open-label Study to Evaluate the Efficacy and Safety of add-on Memantine [5-10 mg b.i.d (10-20 mg/Day)] to Rivastigmine [1.5-6 mg b.i.d. (3-12 mg/Day)] Treatment in Patients With Alzheimer's Disease Who Continued With Rivastigmine Treatment After a Previous Decline While on Donepezil or Galantamine Treatment

Lead sponsor

Novartis

Asset

Rivastigmine

Listed sites

Recruiting sites

Enrollment

204

actual

Study population

Alzheimer’s disease

Key I/E criterion

•Alzheimer's disease

Primary endpoint

•Proportion of responders at the end of phase 2 (vs. end of phase 1)

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 IDCENA713BFR05

NCT IDNCT00234637

Timeline

Milestones

Study start2003-11 (month precision)

Primary completion2005-06actual (month precision)

Study completion2005-06actual (month precision)

Study first posted2005-10-07estimated

Last update posted2011-11-17estimated

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

•Outpatients who have probable Alzheimer's disease according to the DSMIV criteria

•Patients treated with donepezil (5-10 mg ) or galantamine (16- 24 mg) for at least 6 months

•Patients, in the investigator's clinical judgment, not stabilized on treatment with donepezil or galantamine

Exclusion criteria

•Patients with evidence of severe or unstable physical illness, i.e., acute and severe asthmatic conditions, severe or unstable cardiovascular disorders, active peptic ulcer disease, hypersensitivity to cholinesterase inhibitors or memantine, clinically significant laboratory abnormalities or any patient with a medical condition which would prohibit them from completing the clinical trial

Endpoints (5)

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

Executive function / language

Behavior / neuropsychiatric

Caregiver / quality of life

Other (unclassified)

Global cognition

1 endpoint

Primary/protocol endpoint

The proportion of responders (cognitive function stable or improved) at the end of phase 2 (vs. end of phase 1).

threshold achievement, improvement

Executive function / language

1 endpoint

Secondary/protocol endpoint

Change in executive function at weeks 16 and 28 (end of period 1) compared to baseline

change from baseline, improvement

Behavior / neuropsychiatric

1 endpoint

Secondary/protocol endpoint

Change in behavior at weeks 16 and 28 (end of period 1) compared to baseline

change from baseline, improvement

Caregiver / quality of life

1 endpoint

Secondary/protocol endpoint

Change in caregiver burden at weeks 16 and 28 (end of period 1) compared to baseline

change from baseline, improvement

Other (unclassified)

1 endpoint

Secondary/protocol endpoint/low confidence

Change in cognition at weeks 16 and 28 (end of period 1) compared to baseline

change from baseline, improvement

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.