Study in patients suffering of Alzheimer disease in order to learn whether a new compound (ACC-001 with an adjuvant) is safe, acts like a vaccine and has an effect on patient mental performance.
- Conditions
- Patients with mild to moderate Alzheimer's disease.MedDRA version: 14.1Level: PTClassification code 10012271Term: Dementia Alzheimer's typeSystem Organ Class: 10029205 - Nervous system disordersTherapeutic area: Diseases [C] - Nervous System Diseases [C10]
- Registration Number
- EUCTR2009-010922-21-DE
- Lead Sponsor
- Wyeth Pharmaceuticals Inc, a wholly owned subsidiary of Pfizer Inc, 500 Arcola Road, Collegeville, PA 19426 USA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 120
1.Subjects were randomized under previous 3134K1-200-EU study and met all inclusion and none of the exclusion criteria.
2.Subject must have completed through week 78 of study 3134K1-200-EU and received at least 3 doses of investigational product and has been compliant in the opinion of the investigator and sponsor.
3.Screening brain MRI scan is consistent with the diagnosis of AD.
4.Mini-Mental State Examination (MMSE) score >=10.
5.Lives at home with appropriate caregiver capable of accompanying the subject on all clinic visits, or community dwelling with caregiver capable of accompanying the subject on all clinic visits and visiting with the subject approximately 5 times per week for the duration of the study.
6.In the opinion of the investigator, the subject and the caregiver will be compliant and have a high probability of completing the study.
7.The subject and caregiver are likely to be able to participate in all scheduled examinations and complete all required tests.
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 34
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 52
1. Significant neurological disease other than AD that may affect cognition or function.
2. Early termination (ET) from the preceding 3134K1 200-EU study.
3. Experienced a SAE in the preceding double-blind study deemed related to investigational product.
4. Brain MRI evidence of vasogenic edema (VE) during the preceding 3134K1 200-EU study.
5. History of screening visit brain MRI scan indicative of any other significant abnormality including but not limited to more than 4 microhemorrhages (<10 mm), evidence of a single prior hemorrhage > 1 cm3, multiple lacunar infarcts (2 or more) or evidence of a single prior infarct > 1 cm3, evidence of a cerebral contusion, encephalomalacia, aneurysms, vascular malformations, subdural hematoma, or spaceoccupying lesions (eg, arachnoid cysts or brain tumors, such as meningioma).
6. Current clinically important systemic illness that is likely to result in deterioration of the subject’s condition or affect the subject’s safety during the study.
7. Current presence of a clinically significant major psychiatric disorder (e.g., Major Depressive Disorder) according to the criteria of the Diagnostic and Statistical Manual of Mental Disorders,Fourth Edition-Text Revision (DSM-IV-TR), or symptom (e.g.,hallucinations, suicidal ideation, suicidal behavior), that could affect the subject's ability to complete the study.
8. Other clinically significant abnormality on screening visit which includes physical, neurological, laboratory, or electrocardiogram (ECG) examination (eg, atrial fibrillation) that could compromise the study or be detrimental to the subject.
9. Current use of clopidogrel (Plavix) and central nervous system (CNS) stimulants eg, methylphenidate [Ritalin]).
10. Presence of pacemakers, aneurysm clips, artificial heart valves, ear implants, cerebrospinal fluid (CSF) shunts, or metal fragments or foreign objects in the eyes, skin, or body, or claustrophobia that would contraindicate a brain MRI scan.
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