A Clinical Study of Two Doses of a Selective p38 MAP Kinase Inhibitor, VX-745, to Evaluate the Effects of 12-Week Oral Twice-Daily Dosing on Amyloid Plaque Load as Assessed by Quantitative Dynamic 11C-PiB Positive Emission Tomography (PET) Amyloid Scanning
- Conditions
- Alzheimer's diseasedementia1005716710012272
- Registration Number
- NL-OMON44613
- Lead Sponsor
- EIP Pharma, LLC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 16
1. Men and women age 60-85 years.;2. Willing and able to provide informed consent.;3. Confirmed diagnosis of mild cognitive impairment due to Alzheimer*s disease (MCI due to AD) or mild AD.;4. Mini-Mental State Examination (MMSE) score ranging from 20 to 28, inclusive.;5. Evidence of amyloid pathology by Amyloid PET scan determined by visual inspection (any method) by an experienced nuclear medicine physician.;6. If the patient is taking drug for AD (e.g.; donepezil or memantine), he has been on a stable dose for at least 3 months.;7. Dutch-speaking.;8. Adequate visual and auditory abilities to perform all aspects of the cognitive and functional assessments
1. Evidence of neurodegenerative disease other than AD (including but not limited to vascular dementia, dementia with Lewy bodies, and Parkinson*s disease).;2. Subject has any concurrent medical or psychiatric condition that, in the opinion of the investigator, would compromise his/her ability to comply with the study requirements.;3. History of cancer within the last 5 years, except basal cell carcinoma, non-squamous skin carcinoma, prostate cancer or carcinoma in situ with no significant progression over the past 2 years.;4. Significant cardiovascular, pulmonary, renal, liver, infectious disease, immune disorder, or metabolic/endocrine disorders or other disease that would preclude treatment with p38 MAP kinase inhibitor and/or assessment of drug safety and efficacy.;5. History of an allergic reaction of any severity to 11PiB injection.;6. Subject participated in a study of an investigational drug less than 3 months or 5 half-lives of the investigation drug, whichever is longer, before enrollment in this study.;7. Male subjects with female partners of child-bearing potential who are unwilling or unable to adhere to contraception requirements.;8. Female subjects who have not reached menopause or have not had a hysterectomy or bilateral oophorectomy/salpingo-oophorectomy.;9. Positive urine or serum pregnancy test or plans or desires to become pregnant during the course of the trial.;10. Contraindications (e.g. pacemaker, vascular stent or stent graft) to MRI testing.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary efficacy variables are:<br /><br>* Change from Baseline to Week 12 within each treatment group in quantitative<br /><br>relative cortical uptake of 11C-PiB as assessed by dynamic PET scanning at<br /><br>baseline and at end of treatment<br /><br>* Number and proportion of responders by quantitative dynamic PET scanning<br /><br>within each dose group (response defined as *7% reduction in amyloid plaque<br /><br>load)</p><br>
- Secondary Outcome Measures
Name Time Method <p>The secondary efficacy variables are change from Baseline to Week 12 in<br /><br>Mini-Mental State Examination (MMSE), and Wechsler Memory Scale (WMS). No<br /><br>change in cognitive score is anticipated during the brief 12-week period of<br /><br>treatment. Nevertheless, the cognitive assessment will be conducted to<br /><br>determine whether any improvement is observed, and as part of the safety<br /><br>assessment to ensure that there is no marked deterioration of performance.<br /><br><br /><br>In addition, MEG and resting state fMRI data will be obtained in order evaluate<br /><br>for a signal of activity on synaptic function, and to obtain initial treatment<br /><br>effect data to design/size future studies in which one of these measures would<br /><br>be a primary efficacy measure.<br /><br><br /><br>Other endpoints are pharmacokinetics and safety.</p><br>