Effect of Passive Immunization on the Progression of Alzheimer’s Disease: LY2062430 versus Placebo
- Conditions
- Alzheimer’s DiseaseMedDRA version: 9.1Level: LLTClassification code 10001896Term: Alzheimer's disease
- Registration Number
- EUCTR2008-007926-21-FR
- Lead Sponsor
- Eli Lilly and Company
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 1000
1.Meets National Institute of Neurological and Communicative Disorders and Stroke/Alzheimer’s Disease and Related Disorders Association (NINCDS/ADRDA) criteria for probable AD (McKhann et al. 1984; Protocol Attachment LZAN.3) as determined by a neurologist or geriatrician.
2.Has a Modified Hachinski Ischemia Scale (MHIS; Hachinski et al. 1975; Protocol Attachment LZAN.3) score of =4.
3.Has a Folstein MMSE score of 16 through 26 at Visit 1 (Folstein et al. 1975; Protocol Attachment LZAN.3).
4.Has a Geriatric Depression Scale (GDS) score of =6 (on the staff-administered short form).
5.Has had an MRI or computerized tomography (CT) scan performed within the past 2 years has confirmed no findings inconsistent with a diagnosis of AD. Results of this MRI or CT are to be on file at the site. If a patient has not had a prestudy MRI/CT scan in the past 2 years or attempts to obtain offsite imaging results are unsuccessful, then a screening non-contrast head CT is to be performed; due diligence to obtain offsite results should be documented in the patient’s file before obtaining a screening non-contrast head CT scan.
6.Is at least 55 years old, and if a female of childbearing potential, tests negative for pregnancy at Visit 1 and is using a medically accepted means of contraception.
7.If receiving concurrent treatment with an AChEI or memantine, has been on the medication for at least 4 months with a stable dose for at least 2 months before screening. Dosing must remain stable throughout the study.
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
1. Does not have a reliable caregiver who is in frequent contact with the patient (defined as at least 10 hours per week), will accompany the patient to the office and/or be available by telephone at designated times, and will monitor administration of prescribed medications.
2. Meets National Institute of Neurological Disorders and Stroke/ Association Internationale pour la Recherche et l'Enseignement en Neurosciences (NINDS/AIREN) criteria for vascular dementia.
3. Does not have good venous access, such that intravenous drug delivery or multiple blood draws would be precluded.
4. Has current serious or unstable illnesses including hepatic, renal, gastroenterologic, respiratory, cardiovascular (including ischemic heart disease), endocrinologic, neurologic (other than AD), psychiatric, immunologic, or hematologic disease and other conditions that, in the investigator’s opinion, could interfere with the analyses of safety and efficacy in this study; or has a life expectancy of <2 years.
5. Has had multiple episodes of head trauma, or a history within the last 5 years of a serious infectious disease affecting the brain (including neurosyphilis, meningitis, or encephalitis) or head trauma resulting in protracted loss of consciousness.
6. Has a history within the last 5 years of a primary or recurrent malignant disease with the exception of resected cutaneous squamous cell carcinoma in situ, basal cell carcinoma, cervical carcinoma in situ, or in situ prostate cancer with a normal prostrate specific antigen (PSA) posttreatment.
7. Has allergies to humanized monoclonal antibodies.
8. Has a known history of human immunodeficiency virus (HIV), clinically significant multiple or severe drug allergies, or severe posttreatment hypersensitivity reactions (including, but not limited to, erythema multiforme major, linear IgA dermatosis, toxic epidermal necrolysis, or exfoliative dermatitis).
9. Has a history of chronic alcohol or drug abuse/dependence as defined by the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) within the past 5 years.
10. Is clinically judged by the investigator to be at serious risk for suicide.
11. Has a recent (within 6 months before screening) or current laboratory result (if available) indicating a clinically significant laboratory abnormality as determined by the investigator.
12. Has ECG abnormalities obtained at Visit 1 that, in the opinion of the investigator, are clinically significant with regard to the patient’s participation in the study, including corrected QT (QTc) prolongation (Bazett’s corrected QT interval [QTcB] males >458 msec or females >474 msec).
13. At Visit 1, has alanine transaminase (ALT/SGPT) values =2 times the upper limit of normal (ULN) of the performing laboratory, aspartate transaminase (AST/SGOT) values =3 times the ULN, or total bilirubin values =2 times the ULN.
14. Has any contraindications for MRI studies, including claustrophobia, the presence of metal (ferromagnetic) implants, or cardiac pacemaker.
15. Has received AChEIs or memantine for less than 4 months or has less than 2 months of stable therapy on these treatments by Visit 2. (Note: If a patient has recently stopped AChEIs or memantine, he or she must have discontinued treatment at least 2 months before Visit 2.)
16. Has received medications that affect the central nervous system (except treatments for AD) for less than 4 weeks; that is, doses of chronic medications that affect CNS should be stable
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