[No standalone website (unbranded, no questionnaire)] A Study of Subjects With Psoriatic Arthritis to Investigate the Effectiveness of Adalimumab Introduction Compared With Methotrexate Dose Escalation (CONTROL)

How to apply

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Study’s contact

Call center

1-317-615-4559

Condition

Alzheimer Disease

Treatment type

Interventional

Investigational product

LY3002813

Phase

Phase 1

Sponsor

Eli Lilly and Company

ClinicalTrials.gov identifier

NCT02624778

Study number

I5T-MC-AACG

Date first posted

December 4, 2015

Date last update

January 19, 2018

Understanding clinical trials

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About the study

The study will evaluate the effect of LY3002813 on brain scans. The study will evaluate the safety of LY3002813 by looking at adverse events (side effects). The study will also look at the effect the body has on LY3002813. Study participants will have mild cognitive impairment (MCI) due to AD or mild to moderate AD. The study involves 3 parts. - Part A in which participants will receive a single dose of LY3002813 or placebo (no drug). - Part B in which participants will receive multiple doses of LY3002813 or placebo for 24 weeks. - Part C in which participants will receive multiple doses of LY3002813 or placebo for up to 72 weeks. Drug will be given as an intravenous infusion (injection into a vein). For Parts A, B and C, the study will last approximately 72 weeks, not including screening of approximately 56 days. The study is for research purposes only and is not intended to treat any medical condition.

Who can take part?

You may be eligible to participate in the study if you meet the following criteria:

Inclusion criteria
  1. Present with mild cognitive impairment (MCI) due to Alzheimer's disease (AD) or mild-to-moderate AD
  2. Men or nonfertile women, at least 50 years of age. Nonfertile is defined as hysterectomy and/or bilateral oophorectomy, or amenorrhea for at least 1 year
  3. Have up to 2 partners who will provide a separate written informed consent to participate
  4. Have adequate vision and hearing for neuropsychological testing in the opinion of the investigator
  5. Positive florbetapir scan
Exclusion criteria
  1. Do not have up to 2 reliable partners who are in frequent contact with the participant, who will accompany the participant to the office and/or be available by telephone at designated times, and will monitor administration of prescribed medications
  2. Are being monitored for radiation due to occupational exposure to ionized radiation, or exposure to ionizing radiation within last 12 months from an investigational study
  3. History of intracranial hemorrhage, cerebrovascular aneurysm or arteriovenous malformation, or carotid artery occlusion, or stroke or epilepsy
  4. Have any contraindications for magnetic resonance imaging (MRI) studies, including claustrophobia, the presence of contraindicated metal (ferromagnetic) implants, cardiac pacemaker
  5. Have allergies to humanized monoclonal antibodies, including proteins and diphenhydramine, epinephrine, and methylprednisolone
  6. Have gamma globulin therapy within the last year
  7. Previously dosed in any other study investigating active immunization against amyloid beta (Aβ)
  8. Previously dosed in any other study investigating passive immunization against Aβ within the last 6 months
  9. Have current serious or unstable illnesses

For a full list of inclusion/exclusion criteria, please visit ClinicalTrials.gov

Study locations

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How to apply

Determine if a study site for this clinical trial is near you. Contact the study to apply.

Find a Study Site