Phase II clinical study on activity and safety of AFFITOPE® AD02 given to patients with early Alzheimer’s disease
- Conditions
- Patients with early degree of Alzheimer's DiseaseMedDRA version: 14.1Level: LLTClassification code 10001896Term: Alzheimer's diseaseSystem Organ Class: 100000004852Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
- Registration Number
- EUCTR2009-016504-22-CZ
- Lead Sponsor
- AFFiRiS AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 420
-Diagnosis of probable Alzheimer’s disease based on the NINCDS/ADRDA criteria. AD of early degree has been confirmed if the Mini Mental State Examination (MMSE) score is =20 (1).
or
-Patients fulfilling inclusion criteria 4/4a and 6 (2).
PLEASE NOTE: the study manual (version 1, based on study protocol V04 (22Jul2010) contained some more explanations regarding inclusion criterion (1). These were provided following comments of investigators. A more specific update of these explanations is now provided in the protocol:
Regarding (1): NINCDS/ADRDA criteria, it is obvious that patients with a MMSE =27 might not fulfill all NINCDS/ADRDA. This encompasses primarily criteria referring to or requiring a state of dementia (e.g., under section I, dementia was established by clinical examination and documented by MMSE, …”). In such a case, inclusion criterion (2) ensures the specificity of the diagnosis (predementia stage of AD/AD-type MCI). Patients with a MMSE =19 are clearly excluded by criterion (1) which reflects the overall goal of recruiting patients with early” AD.
-Hachinski Ischemia Scale is used to distinguish AD from vascular dementia. A score of = 4 suggests AD (3).
-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 (score =2) (4).
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 (psychiatrist, neurologist or psychologist dependent on the regulations in a given country)(5).
-A FCSRT result of total recall =40 or free recall =17 indicative of hippocampal damage in the patient’s episodic memory according to Dubois and colleagues to enrich the population for AD patients. (6).
-Age between 50 and 80 years, if not approved by AFFiRiS (7).
-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. This is necessary because some of the neuropsychiatric tests require information by a person knowing the patient well. In addition, it increases the safety of a study participant (8).
-Adequate visual and auditory acuity to allow neuropsychological testing (9).
-Female patients of childbearing potential are eligible if they use a medically accepted contraceptive method (10).
-Availability of the APOE genotype (11).
-A potential participant receiving 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 (12).
-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, in case of uncertainty please contact sponsor (13).
-Scheduled elective hospitalization for diagnostic work-up is allowed for inclusion into the clinical trial (14).
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 140
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 280
-Pregnant women (1).
-Sexually active women of childbearing potential who are not using a medically accepted birth control method and unreliable contraception in male subjects (2).
-Participation in the active treatment phase of another clinical trial within 3 months before Visit 1 (3).
-History of questionable compliance to visit schedule; patients not expected to complete the clinical trial (4).
-Presence or history of allergy to components of the vaccine, if considered relevant by the investigator (5).
-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 (6).
-Inability to tolerate MRI procedure (e.g., claustrophobia, inability to lie motionless for 30 minutes, noise sensitivity) (7).
-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 (8).
-Operation under general anaesthesia within 3 months prior to study entry and scheduled elective operation under general anaesthesia during the whole study period (9).
-History and/or presence of autoimmune disease; please note: for example, positive ANAs without clinical symptoms do not represent disease”, in case of uncertainty please contact sponsor for more detailed information (10).
-Recent (=5 years since last specific treatment) history of cancer (Exceptions: basal cell carcinoma, intraepithelial cervical neoplasia) (11).
-Active infectious disease (e.g., Hepatitis B, C) (12).
- Presence and/or history of Immunodeficiency (e.g., HIV infection) (13).
-Significant systemic illness (e.g., chronic renal failure, chronic liver disease, poorly controlled diabetes, poorly controlled congestive heart failure, other deficiencies) (14).
-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 (15).
-History of significant psychiatric illness such as schizophrenia, bipolar affective disorder or psychotic depression (16).
-Current depressive episode (Geriatric Depression Scale (GDS) >5 at Visit 1)(17).
-Metabolic or toxic encephalopathy or dementia due to a general medical condition (18).
-Alcoholism or substance abuse within the past year (alcohol or drug intoxication) (19).
-Wernicke’s encephalopathy (20).
-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.)(21).
-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 (22).
-Epilepsy (23).
-Prior and/or current tr
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