Randomized, Double-blind Study to Evaluate the Tolerability of 2 Different Titration Methods of Rivastigmine Patch in AD Patients (MMSE 10-20)

Novartis

Status and phase: Completed; Phase 3

Conditions: Alzheimer's Disease

Treatments: Drug: Active Comparator; Drug: ENA713

Study type: Interventional

Funder types: Industry

Identifiers

NCT01614886

CENA713D1303

Details and patient eligibility

About

To evaluate the tolerability, safety and efficacy of 3-step titration versus 1-step titration of Rivastigmine patch in the Japanese population.

Enrollment: 216 patients

Sex: All

Ages: 50 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• A diagnosis of dementia of the Alzheimer's type according to the DSM-IV criteria
• A clinical diagnosis of probable AD according to NINCDS/ADRDA criteria
• An MMSE score of ≥ 10 and ≤ 20 at baseline

Exclusion criteria

• Any medical or neurological conditions other than AD that could explain the patient's dementia
• A current diagnosis of probable or possible vascular dementia
• A score of > 5 on the Modified Hachinski Ischemic Scale (MHIS)
• A current DSM-IV Axis 1 diagnosis that may interfere with the evaluation of the patient's response to study medication.
• Treated with donepezil or galantamine within last 4 weeks before the efficacy assessment at baseline.
• an advanced severe progressive or unstable disease of any type that may interfere with efficacy and safety assessments or put the patient's at special risk
• Other protocol-defined inclusion/exclusion criteria may apply.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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216 participants in 2 patient groups

1 step

Experimental group

Treatment:

Drug: Active Comparator

3 step

Active Comparator group

Treatment:

Drug: ENA713