A Phase I/II Double-Blind, Randomised, Placebo-Controlled, Adaptive Design Study of the Safety, Tolerability, Immunogenicity and Efficacy of ACI-24 in Patients with Mild to Moderate Alzheimer's Disease

AC Immune SA0 sites48 target enrollmentDecember 19, 2008

Overview

No summary available.

Registry

who.int

Start Date

December 19, 2008

End Date

October 16, 2018

Last Updated

6 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•1\. Probable AD according to NINCDS\-ADRDA criteria
•2\. Florbetaben\-PET scan at screening consistent with the presence of amyloid pathology
•3\. Mini\-Mental Status Examination (MMSE) 18 – 28 points\*
•4\. Age over 40 and less than 90 years\*\*
•5\. Patients receiving a stable dose of an acetylcholinesterase inhibitor for at least 4 months prior to baseline
•6\. Patients cared for by a reliable spouse or caregiver to assure compliance, assist with clinical assessments and report safety issues
•7\. Women must be post\-menopausal for at least one year, surgically sterilized or using reliable contraceptive measures
•8\. Patient who in the opinion of the investigator are able to understand and provide written informed consent
•9\. Patients and caregivers must be fluent in one of the languages of the study and able to comply with all study procedures
•10\. The patient is lucid and clear and oriented x4 and is able to provide their written informed consent (applicable in Sweden only).

•1\. Patients whose MRI scan within the last 6 months shows alternative pathology including severe vascular encephalopathy and/or more than 5 micro\-haemorrhages.
•2\. Patients with other medical conditions which may influence cognitive performance e.g. Parkinson’s disease
•3\. Patients with any unstable medical condition (e.g. epilepsy, uncontrolled hypertension) which would hamper safety assessments
•4\. Patients receiving memantine within 3 months prior to baseline (for cohort 3 booster injection, memantine is allowed)
•5\. Patients receiving any anticoagulant drugs
•6\. Patients with a history of hemorrhagic stroke
•7\. Patients with a history of non\-hemorrhagic stroke or myocardial infarction within the last year
•8\. Patients with a history of major psychiatric disorder within the past 2 years
•9\. Patients with a history of inflammatory neurology disorders including meningoencephalitis
•10\. Clinically significant abnormalities of clinical haematology or biochemistry including, but not limited to, elevations greater than 1\.5 times the upper limit of normal of SGOT, SGPT, or creatinine