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Find more clinical trials

MSDC-0160 Effects on Brain Glucose Utilization, Cognition & Safety in Alzheimer's Disease

Start: July 2011
End: May 2013
Enrollment: 40

What Is This Study About?

This study will evaluate the effect of 150 mg of MSDC-0160, taken daily for 90 days, compared to the effect of a placebo on changes in brain glucose utilization using FDG-PET and cognition in older people with mild Alzheimer's disease. Safety and tolerability of MSDC-0160 in this population will also be studied. These results will be used to design larger studies of MSDC-0160 in persons with mild Alzheimer's.

Do I Qualify To Participate in This Study?

Minimum Age: 55 Years

Maximum Age: 85 Years

Must have:

++Male or females 55-85 years of age++Diagnosis of probable Alzheimer's disease with MMSE scores of 20 or greater ++Females should be either postmenopausal or surgically sterilized++Males with female partners of child-bearing potential must use contraception if engaging in sexual intercourse++Willing and able to take part in up to six study visits over a 5-month period, with the support of a caregiver as needed

Must NOT have:

++Diagnosis of diabetes, including use of anti-diabetic medications, or fasting blood glucose over 125 mg/dl, or Hemoglobin A1c greater than 6.4% ++Unable to participate in FDG-PET scanning++Diagnosis of significant neurological/psychiatric disease other than AD, including but not limited to, any of the following: vascular dementia, space occupying cerebral lesion, Huntington's disease, Parkinson's disease, normal pressure hydrocephalus, and seizures++History of heart failure++Previous cardiovascular event (myocardial infarct, bypass surgery, or PTCA) within the past 6 months prior to screening ++Inability to undergo a clinical MRI of the brain without contrast and lack of a usable (less the 12 months prior to screening) MRI on record. Contraindications to undergoing an MRI of the brain include but are not limited to, pacemakers; implantable cardioverter defibrillators; cochlear implants; cerebral aneurysm clips; implanted infusion pumps; implanted nerve stimulators; metallic splinters in the eye; and, other magnetic, electronic or mechanical implants++ALT and/or AST levels that are twice the upper limit of normal++Malignancy (other than non-melanoma skin cancer) within the last 5 years++Known history of HIV, hepatitis B, or hepatitis C++Blood pressure greater than 160/100 mmHg++History of alcohol or drug abuse within 6 months of screening++Participated in an investigational study or received an investigational drug within 30 days or 5 half-lives (whichever is longer) prior to study drug administration++Any surgical or medical condition that may significantly alter the absorption of any drug substance, including, but not limited to major gastrointestinal tract surgery, currently active inflammatory bowel syndrome++Evidence of clinically relevant pathology that in the investigator's opinion could interfere with the study results or put the participant's safety at risk++Change in medications to treat AD within 3 months prior to screening++Change in medicatino to treat other conditions within 6 weeks prior to screening or during the study period

If I Qualify, Who Do I Contact?

Contact study personnel listed either under the general study contact or the location nearest you.

Need Help?

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?

Who Sponsors This Study?

Lead: Metabolic Solutions Development Company

Source: ClinicalTrials.gov ID: NCT01374438

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An official website of the U.S. government, managed by the National Institute on Aging at the National Institutes of Health