Effects of Dopaminergic Therapy in Patients With Alzheimer's Disease
Status:
Completed
Trial end date:
2018-11-01
Target enrollment:
Participant gender:
Summary
This is phase IIa 24-week, prospective, randomized, double-blind placebo controlled study.
The study is designed to evaluate the efficacy, safety, and tolerability of transdermal patch
of Rotigotine (RTG) versus placebo (PLC) as add-on therapy with AChEI in patients with mild
AD according to the consensus diagnostic criteria and MMSE score of ≥18 and ≤24 at screening.
Two groups of patients with mild AD will be involved (50 patients each). One group will be
assigned to treatment with RTG 4 mg and the other one to PLC as add on to AChEI therapy
(Rivastigmine). Clinical and neurophysiological measurements will be collected before and
after drug administration.
Phase:
Phase 2
Details
Lead Sponsor:
I.R.C.C.S. Fondazione Santa Lucia
Treatments:
Dopamine Dopamine Agents Dopamine Agonists N 0437 Rotigotine