A double-blind placebo-controlled study of the safety, tolerability and efficacy of 12 months’ treatment with ACI 91 in patients with mild to moderate Alzheimer’s Disease

Conditions: mild to moderate Alzheimer’s Disease
MedDRA version: 9.1Level: LLTClassification code 10001896Term: Alzheimer's disease

Registration Number: EUCTR2008-005260-14-AT

Lead Sponsor: AC Immune SA

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 60

Inclusion Criteria

- Patients with a documented diagnosis of probable Alzheimer’s Disease” according to NINDS-ADRDA criteria supported by the results of a brain MRI scan made within one year of screening
- Patients with MMSE 18 – 26 at screening
- Male and female patients of age 40-85 years
- Patients cared for by a reliable caregiver either living-in or visiting on a daily basis to assure compliance, assist with clinical assessments to make sure that safety issues are reported
- Women must be post-menopausal for at least one year, surgically sterilised or using reliable contraceptive measures, eg. oral contraceptive or double-barrier method
- Patients who in the opinion of the investigator are likely to cooperate with the requirements of the study, able to hear, see and speak adequately to conduct the assessments and able to swallow the study medication
- Patients receiving stable dose of acetylcholinesterase inhibitors for at least 4 months prior to screening.
- Patients and caregivers must be fluent in German and able to comply with all study procedures
- Patients giving written informed consent (ability to give consent).

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- 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
- Patients with elevated prothrombin or partial thromboplastin time
- Patients with a major depressive episode within the past 2 years or a history of recurrent major depression or a history of bipolar disorders according to DSM-IV criteria
- Patients with a Hamilton Depression (17 Item) Scale total score of 14 or greater or an individual item score of 3 or greater on Depressed Mood, Feelings of Guilt or Suicide at screening.
- Past or present history of abuse of drugs or alcohol
- Patients with stroke or myocardial infarction within the past year
- Participation in a trial of another investigational drug within the last three months prior to screening
- Patients with other medical conditions which may influence cognitive performance e.g. Parkinson’s disease, normal pressure hydrocephalus, progressive supranuclear palsy brain tumor, recurrent seizures, subdural hematoma, multiple sclerosis, severe head injury with coma lasting for more than a day
- Patients with an alternative cause for dementia as determined by MRI scan within 1 year prior to the study, at a time when the patient was known to be demented. Diffuse periventricular white matter changes need not result in exclusion.
- Patients with vascular dementia according to NINDS-AIREN criteria
- Patients with Vitamin B12 or folate deficiency or hypothyroidism unless on replacement therapy for at least three months.
- Patients with a positive HIV and/or syphilis test at screening
- Patients with closed angle glaucoma
- Patients with symptomatic prostatic hypertrophy
- Patients with any unstable medical condition which might alter the ability to complete the clinical study.
- Patients with moderate or severe renal or hepatic impairment
- Patients unable to undergo MRI examination for any reason, including claustrophobia
- Patients who are lactating, pregnant or planning to be pregnant, or who have a positive pregnancy test at screening (women of childbearing potential)
- Patients receiving anticoagulant drugs
- Patients receiving anticholinergic drugs, eg oxybutinin, tolteridone, tricyclic antidepressants
- Patients receiving neuroleptic drugs other than atypical antipsychotics
- Patients receiving pirenzepine
- Patients receiving antioxidants including Coenzyme Q10 or high dose vitamins (5 times the recommended dose of Vitamin E or Vitamin C)
- Patients receiving MAO-A or MAO-B inhibitors eg selegiline, rasagiline
- Patients receiving putative cognitive enhancers other than acetylcholinesterase inhibitors (eg ergoloid mesylates, nimodipine, piracetam, gingko biloba).
- Patients receiving memantine currently or previously
- Patients with a major psychiatric illness within the past 5 years
- Patients who have been hospitalized involuntarily or at the request of the caregiver