Alzheimer's Disease
Conditions
Keywords
Dementia,, Alzheimer's,, Rivastigmine,, Memantine
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)
Interventions
Sponsors
Novartis
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to 85 Years
Healthy volunteers
No
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/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety and tolerability of treatment with memantine and rivastigmine, measured by the incidence of GI adverse events (nausea and vomiting) | — |
Secondary
| Measure | Time frame |
|---|---|
| Whether patients on rivastigmine and memantine are able to reach and maintain higher doses of rivastigmine compared to historical data of rivastigmine monotherapy | — |
Countries
United States
Outcome results
None listed