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)
1 other identifier
interventional
150
1 country
1
Brief Summary
This is a prospective, 26-week, open-label, single-arm multi-center pilot study. Eligible patients will receive open-label treatment with rivastigmine capsules plus memantine tablets as add on therapy. This study is designed to evaluate the safety and tolerability of add on therapy with memantine to rivastigmine capsules in patients with probable AD (MMSE 10-20)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Mar 2006
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2006
CompletedFirst Submitted
Initial submission to the registry
March 20, 2006
CompletedFirst Posted
Study publicly available on registry
March 22, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2007
CompletedDecember 21, 2007
December 1, 2007
March 20, 2006
December 17, 2007
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Safety and tolerability of treatment with memantine and rivastigmine, measured by the incidence of GI adverse events (nausea and vomiting)
Secondary Outcomes (1)
Whether patients on rivastigmine and memantine are able to reach and maintain higher doses of rivastigmine compared to historical data of rivastigmine monotherapy
Interventions
Eligibility Criteria
You may qualify if:
- 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;
You may not qualify if:
- 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;
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Novartislead
Study Sites (1)
Unknown Facility
Paterson, New Jersey, 08759, United States
Related Publications (1)
Sadowsky CH, Dengiz A, Meng X, Olin JT; US38 Study Group. Switching from oral donepezil to rivastigmine transdermal patch in Alzheimer's disease: 20-week extension phase results. Prim Care Companion J Clin Psychiatry. 2010;12(5):PCC.09m00852. doi: 10.4088/PCC.09m00852oli.
PMID: 21274364DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Novartis
862-778-8300
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
March 20, 2006
First Posted
March 22, 2006
Study Start
March 1, 2006
Study Completion
August 1, 2007
Last Updated
December 21, 2007
Record last verified: 2007-12