Clinical Pharmacology of p38 MAP Kinase Inhibitor, VX-745, in Mild Cognitive Impairment Due to Alzheimer's Disease (AD) or Mild AD
| Status: | Completed |
|---|---|
| Conditions: | Alzheimer Disease, Cognitive Studies |
| Therapuetic Areas: | Neurology, Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 60 - 85 |
| Updated: | 4/17/2018 |
| Start Date: | April 2015 |
| End Date: | November 2016 |
A Randomized, Open-Label, Multiple Dose Clinical Pharmacology Study of Two Doses of a Selective p38 MAP Kinase Inhibitor, VX-745 in Patients With Mild Cognitive Impairment (MCI) Due to Alzheimer's Disease (AD) or With Mild AD
This study will assess the effects of VX-745 on markers of disease in the central nervous
system of patients with MCI due to AD or with mild AD. The study will also evaluate the
safety and tolerability of VX-745 in these patients during 6 weeks of dosing, as well as the
plasma and cerebrospinal fluid concentrations of VX-745 during dosing.
system of patients with MCI due to AD or with mild AD. The study will also evaluate the
safety and tolerability of VX-745 in these patients during 6 weeks of dosing, as well as the
plasma and cerebrospinal fluid concentrations of VX-745 during dosing.
Inclusion Criteria:
- Age 60 - 85 (inclusive)
- Willing and able to provide informed consent
- Clinical presentation consistent with MCI due to AD or of mild AD
- Gradual progressive decline in memory function over >6 months
- Amnestic presentation on neuropsychological testing with rapid forgetting (%
reduction 1.5 standard deviations below the mean)
- Clinical Dementia Rating (CDR) Sum of Box (SOB) score ≥0.5
- Mini-Mental State Examination (MMSE) range: 20 to 30
- Brain hypometabolism by 18F-2-fluoro-2-deoxyglucose (FDG)-PET
- Participants may be taking medications for AD, provided that the dose of these
medications has been stable for >3 months.
Exclusion Criteria:
- Evidence of neurodegenerative disease other than AD
- Inability for any reason to undergo MRI scans (e.g. pacemaker, vascular stent or stent
graft). Patients who require sedation for screening procedures such as MRI may receive
a short-acting sedative.
- Psychiatric disorder that would compromise ability to comply with study requirements
- 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
- 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
- Recent (<90 days) changes to AD medications prescribed for cognitive reasons or with
the potential to impact cognition
- Psychotropic drugs taken within 1 month. Anticoagulant drugs taken within 1 week.
- Participation in a study of an investigational drug less than 6 months or 5 half-lives
of the investigational drug, whichever is longer, before enrollment in the study
- Male subjects with female partner of child-bearing potential who are unwilling or
unable to adhere to contraception requirements
- Female subjects who have not reached menopause or have not had a hysterectomy or
bilateral oophorectomy/salpingoophorectomy
- Positive urine or serum pregnancy test or plans desires to become pregnant during the
course of the trial
- Donation of >500 mL of blood or blood products within 2 months
- History of alcohol and/or illicit drug abuse within 6 months.
- Infection with hepatitis A, B or C or HIV.
- Any factor deemed by the investigator to be likely to interfere with study conduction
We found this trial at
1
site
Glendale, California 91206
Principal Investigator: Hakop Gevorkyan, MD
Phone: 855-814-8631
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