A randomised, controlled, parallel group, double-blind, multi-center, phase II study to assess the clinical- and immunological activity as well as the safety and tolerability of different doses/formulations of AFFITOPE AD02 administered repeatedly to patients with mild Alzheimer’s disease. - AFFiRiS006
- Conditions
- Patients with mild degree of Alzheimer's DiseaseMedDRA version: 12.0Level: LLTClassification code 10001896Term: Alzheimer's disease
- Registration Number
- EUCTR2009-016504-22-FR
- Lead Sponsor
- AFFiRiS AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 420
Confirmed diagnosis of probable & mild Alzheimer’s disease
-Diagnosis of probable Alzheimer’s disease based on the NINCDS/ADRDA criteria.
-Assessing the severity of Alzheimer’s disease of mild degree by the Mini Mental State Examination (MMSE). AD of mild degree has been confirmed if the MMSE score is =20.
-Hachinski Ischemia Scale is used to distinguish AD from vascular dementia. A score of = 4 suggests AD.
-The result of the Magnetic Resonance Imaging scan (MRI) of the patient’s brain has to be consistent with the diagnosis of AD, central reading. This includes medial temporal lobe atrophy as assessed by the Scheltens scale.
Further conditions for inclusion into the clinical trial
-Written informed consent signed and dated by the patient and the caregiver. The patient’s capability to give informed consent has to be confirmed by an independent professional.
-Deterioration in the patient’s episodic memory test (according to Dubois and colleagues; cut-off: total recall: <40, cued recall: <17).
-Age between 50 and 80 years.
-Availability of a partner/caregiver knowing the patient and being able to accompany the patient at the visits and being available for the telephone interviews.
-Adequate visual and auditory acuity to allow neuropsychological testing.
-Female patients of childbearing potential are eligible if they use a medically accepted contraceptive method.
-Availability of the APOE genotype.
-A potential participant treated with conventional AD and hypothyreoidism therapies must be on stable doses for at least 3 months prior to Visit 1 and during the entire trial period.
-A potential participant has to be on stable doses of all medications he/she is taking because of consisting illnesses according to medical history (except AD and hypothyreoidism therapies, AD therapies will be recorded separately) for at least 30 days prior to Visit 1.
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
-Pregnant women.
-Sexually active women of childbearing potential who are not using a medically accepted birth control method.
-Participation in another clinical trial within 3 months before Visit 1.
-History of questionable compliance to visit schedule; patients not expected to complete the clinical trial.
-Presence or history of allergy to components of the vaccine, if considered relevant by the investigator.
-Contraindication for MRI imaging, including but not limited to pacemakers; cochlear implants, cerebral aneurysm clips; implanted infusion pumps; implanted nerve stimulators; metallic splinters in the eye; other magnetic, electronic, or mechanical implants; or any other clinical history or examination finding that, in the judgement of the investigator, would pose a potential hazard in combination with MRI.
-Inability to tolerate MRI procedure (e.g., claustrophobia, inability to lie motionless for 30 minutes, noise sensitivity).
-MRI findings at Visit 1 excluding participation: a significant number of microhemorrhages, a single prior hemorrhage > 1 cm3, 2 or more lacunar infarcts , a single prior infarct > 1 cm3, a single strategically located subcortical infarct (e.g., thalamus, hippocampus, left caudate head), evidence of a meningioma, cerebral contusion, encephalomalacia, or aneurysms, evidence of other dementia (non-AD) pathology.
-Operation (under general anaesthesia) within 3 months prior to study entry and scheduled elective operation during the whole study period.
-History and/or presence of autoimmune disease.
-Recent (=5 years since last specific treatment) history of cancer (Exceptions: basal cell carcinoma, intraepithelial cervical neoplasia).
-Active infectious disease (e.g., Hepatitis B, C).
- Presence and/or history of Immunodeficiency (e.g., HIV).
-Significant systemic illness (e.g., chronic renal failure, chronic liver disease, poorly controlled diabetes, poorly controlled congestive heart failure, other deficiencies).
-Hypothyroidism, defined as any significant thyroid-stimulating hormone elevation. Patients with corrected hypothyroidism are eligible for the study provided that treatment has been stable for 3 months before study entry.
-History of significant psychiatric illness such as schizophrenia, bipolar affective disorder or psychotic depression.
-Current depressive episode (Geriatric Depression Scale (GDS) >5 at Visit 1)
-Metabolic or toxic encephalopathy or dementia due to a general medical condition.
-Alcoholism or substance abuse within the past year (alcohol or drug intoxication).
-Wernicke’s encephalopathy
-History or evidence of any other CNS disorder that could be interpreted as a cause of dementia (infectious or inflammatory/demyelinating CNS conditions, Creutzfeld Jacob disease, Parkinson’s disease, Huntington’s disease, brain tumor, subdural haematoma, etc.)
-History or evidence of cerebrovascular disease (stroke, transient ischemic attack, hemorrhage), or diagnosis of possible, probable or definite vascular dementia in accordance with NINDS-AIREN criteria.
-Epilepsy.
-Prior and/or current treatment with experimental immunotherapeutics including IVIG, AD antibody therapy and/or vaccines for AD including AFFITOPE AD01&AD02.
-Prior and/or current treatment with immunosuppressive drugs.
-Benzodiazepines administered on a chronic basis.
-Change in dose of standard treatments for AD or hypothyroidism within 3 months prior to Visit 1.
-Change in dose of previous and current medications which the patie
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method