MSDC-0160 Effects on Brain Glucose Utilization, Cognition & Safety in Alzheimer's Disease
MSDC-0160 Effects on Brain Glucose Utilization, Cognition & Safety in Alzheimer's Disease
Overall Status:
No longer recruiting
Brief Description:
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.
Patient Qualifications:
| Min Age | Max Age | Gender | Healthy Volunteers |
|---|---|---|---|
55 Years | 85 Years | Both | No |
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Detailed Description:
The objective is to examine the feasibility of conducting future large-scale studies on the efficacy of MSDC-0160 in people with mild AD. Efficacy and safety will be assessed by estimating the effect size of 150 mg daily MSDC-0160 versus placebo on 3-month change in:
- brain glucose utilization, as meadured by FDG-PET and voxel-based analysis
- change in cognitive function, as determined by results of a neuropsychological battery of 19 tests and ADAS-Cog subscale
- 9-item executive function scale
The study will also explore whether baseline levels of peripheral inflammatory biomarkers or genotypes, including but not limited to the apolipoprotein ε4 allele, explain the heterogeneity in the baseline level of brain glucose utilization and, in MSDC-0160 users, 3-month brain glucose utilization. Also examined will be whether changes in peripheral inflammatory biomarkers correlate with changes in 3-month brain glucose utilization in MSDC-0160 users.
Locations:
| Map Marker | City | State | Zip Code | Status |
|---|---|---|---|---|
Geolocation is 0, 0 | Chicago | Illinois | 60612 | Recruiting |
Lead Sponsor:
| Agency |
|---|
Metabolic Solutions Development Company |
Collaborator Sponsor:
Facility Investigators:
| Name | Role | Affiliation |
|---|---|---|
Jerry R. Colca, PhD | Study Director | MSDC |
Raj C. Shah, MD | Principal Investigator | Rush Memorial University Medical Center |
Study Contact:
| Name | Phone |
|---|---|
Lindsay Franti | (312) 563-4111 |
Locations
ClinicalTrials.gov ID
NCT01374438 (follow link to view full record on ct.gov in new window)
Official Title:
A 3-month Randomized, Double-Blind, Placebo-Controlled, Feasibility Study to Evaluate the Effects of MSDC-0160 on Brain Glucose Utilization, Cognition, Safety and Tolerability in Older Persons with Mild Alzheimer's Disease
Study Start Date:
July 2011
Study End Date:
December 2012
Disease Stage:
Early
Enrollment:
40
