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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00234637

Enrollment

204

Registered

2005-10-07

Start date

2003-11-30

Completion date

2005-06-30

Last updated

2011-11-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alzheimer's Disease

Keywords

Alzheimer's disease,, switch,, rivastigmine,, memantine

Brief summary

This is a prospective, multicenter, open-label study. Following screening and baseline assessments, eligible patients will be switched to rivastigmine and will enter the 16 week run-in rivastigmine treatment phase. After completion of assessments at the end of the run-in phase, patients who were not sufficiently stabilized on rivastigmine alone will receive add-on memantine to their rivastigmine treatment; patients who were stabilized on rivastigmine alone will have completed and be discontinued from the study.

Interventions

DRUGRivastigmine, memantine

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

50 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
Change in cognition at weeks 16 and 28 (end of period 1) compared to baseline	—
Change in caregiver burden at weeks 16 and 28 (end of period 1) compared to baseline	—
Change in behavior at weeks 16 and 28 (end of period 1) compared to baseline	—
Change in executive function at weeks 16 and 28 (end of period 1) compared to baseline	—

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026