Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study Comparing 3 Mg And 12 Mg Of Ly3202626 With Placebo Over 52 Weeks In Approximately 500 Patients With Mild Alzheimer’S Disease Dementia.
Posted Date: Apr 30, 2018
- Investigator: Lawrence Goldstick
- Type of Study: Drug
This study is being done to see how safe a new investigational drug is and how well it might work to help people with Alzheimer’s disease. “Investigational” means that the drug being tested has not been approved for sale or routine clinical use in the United States by the U.S. Food and Drug Administration (FDA). However, the FDA has allowed the use of this drug for research. Florbetapir (F18) injection and 18F-AV-1451 injection are imaging agents. Each one includes a small amount of radioactivity (radiation) that is necessary to create PET scan images or pictures. Florbetapir (F18) is approved by the United States Food and Drug Administration (FDA) to see how much amyloid protein has accumulated in the brains of adults who are being checked for Alzheimer’s disease and other possible causes for problems with thinking and remembering. The use of 18F-AV-1451 is experimental in the U.S. This means that it is not approved for sale or use in the United States by the FDA, and it is approved for use only in clinical studies. How well this test works is not fully known, and it will be tested during the study. This study may help to answer the following research question(s): ? The safety of LY3202626 and any side effects a person might have when he/she takes it. ? Whether LY3202626 can help people with Alzheimer’s disease. ? How much LY3202626 should be given to people. In addition, this study will compare LY3202626 with a placebo to see if taking LY3202626 is better than taking a placebo. The placebo is a capsule that looks like a drug but has no drug in it.
You Cannot Be In This Study If: ? You Have Certain Neurologic Diseases Or Psychiatric Disorders. ? You Have Had Cancer In The Past 5 Years. ? You Are Not Able To Have A Magnetic Resonance Imaging (Mri) Scan. ? You Are Taking Or Have Taken Certain Medications Or Therapies Such As Alzheimer’S Disease Vaccines. ? You Have Unstable Health Problems That Could Interfere With The Study Or Make It Unsafe For You To Be In The Study. ? You Are Participating In Another Study, Unless Approved By The Study Sponsor. ? You Are An Employee Of The Investigative Site Or You Are An Immediate Family Member Of An Employee Of The Investigative Site. Immediate Family Member Is Defined As A Spouse, Parent, Child, Or Sibling, Whether Biological Or Legally Adopted. ? You Are An Employee Of Eli Lilly And Company. What Will Happen During The Study? If You Agree To Be In The Study, You Will Be Asked To: ? Sign This Consent Form; ? Give Some Personal Information (Such As Date Of Birth, Gender, Race/Ethnicity) And Have Your Height And Weight Checked; ? Give Your Health History. The Study Staff Will Review Your Medical History And Test Results To See If You Can Be Part Of This Study. ? Tell The Study Staff If You Take Any Over-The-Counter Or Prescription Drugs, Vitamins, Or Herbs. The Study Staff Will Discuss What Is Required For You To Be Part Of This Study. You May Need To Have Some Exams Or Tests Done To Find Out If You Are A Candidate To Begin The Study Drug. Some Of These Tests May Be Done As Part Of Your Normal Care Even If You Do Not Join The Study. If You Decide To Continue In This Study And The Study Doctor Says You Can Continue In The Study, You Will Be “Randomized” Into One Of Three Study Groups: ? 3 Mg Ly3202626 Capsule, By Mouth, Once Per Day ? 12 Mg Ly3202626 Capsule, By Mouth, Once Per Day ? Placebo Capsule, By Mouth, Once Per Day Randomization Means That You Are Placed Into A Group By Chance (Like The Flip Of A Coin). You Have An Equal Chance Of Being In Any Of The Three Study Groups. Neither You Nor Your Study Doctor Can Choose The Group That You Will Be Placed In. Neither You Nor The Study Doctor Will Know What You Are Taking. Whether You Receive Ly3202626 Or Placebo Will Be Determined By Chance. Your Study Doctor May Find Out Which Study Drug You Are On If Needed For Your Care. If This Happens, The Study Doctor May Not Be Able To Tell You Which Study Drug You Are On Until Everyone Finishes The Study (Which May Be Years In Some Cases)
Dementia, Eli Lilly, Alzheimer’S Disease, Ly3202626, Null
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