Start: February 2014
End: December 2020
What Is This Study About?
This study will test whether an investigational drug, solanezumab, can slow the progression of memory problems associated with amyloid, a protein that forms plaques in the brains of people with Alzheimer disease. Participants who have normal thinking and memory function but may be at risk for developing Alzheimer's dementia are invited to participate. All volunteers will undergo a positron emission tomography (PET) scan to be determine their brain amyloid levels.
Do I Qualify To Participate in This Study?
- Mini-Mental State Examination (MMSE) score of 25-30 inclusive
- Global Clinical Dementia Rating (CDR) scale score of 0
- Logical Memory II score of 6-18
- PET scan that shows evidence of amyloid in the brain at screening
- Study partner who has at least weekly contact with the participant (contact can be in person, via telephone, or by e-mail or other electronic means) and can provide information about him or her
Must NOT have:
- Taking a prescription Alzheimer's medication (acetylcholinesterase inhibitor and/or memantine)
- Lack of good venous access that precludes intravenous drug delivery or multiple blood draws
- Current serious or unstable illness, including cardiovascular, hepatic, renal, gastroenterologic, respiratory, endocrinologic, neurologic, psychiatric, immunologic, or hematologic disease or other conditions that could interfere with the study
- 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
- 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 normal prostate-specific antigen post-treatment
- Known history of human immunodeficiency virus (HIV), clinically significant multiple or severe drug allergies, or severe post-treatment hypersensitivity reactions, including but not limited to erythema multiforme major, linear immunoglobulin A dermatosis, toxic epidermal necrolysis, or exfoliative dermatitis
- At serious risk for suicide; history within the past 2 years of major depression or bipolar disorder
- History within the past 5 years of chronic alcohol or drug abuse/dependence
- Residence in a skilled nursing facility or nursing home
If I Qualify, Who Do I Contact?
Contact study personnel listed either under the general study contact or the location nearest you.
Who Is the General Study Contact?
For more information about the A4 trial or study sites, please visit www.a4study.org. You may also call 1-844-A4-STUDY (1-844-247-8839) or e-mail A4email@example.com.
Alzheimer's Therapeutic Research Institute
Contact NIA’s Alzheimer’s and related Dementias Education and Referral (ADEAR) Center at 800-438-4380 or email ADEAR.
Where Is This Study Located?
Lead: Eli Lilly and Company
Alzheimer's Therapeutic Research Institute (ATRI)
Source: ClinicalTrials.gov ID: NCT02008357