Phase 2
Completed N=9
Clinical Pharmacology of p38 MAP Kinase Inhibitor, VX-745, in Mild Cognitive Impairment Due to Alzheimer's Disease (AD) or Mild AD
Source: ClinicalTrials.gov NCT02423200 ↗Enrolled (actual)
9
Serious AEs
0.0%
Results posted
Apr 2018
Primary outcomePrimary: Percent Change From Baseline to End of Treatment in Cerebrospinal Fluid Levels of Cytokines — 137 percentage of baseline at Day 42
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change From Baseline to End of Treatment in Cerebrospinal Fluid Levels of Cytokines |
137 | — |
| SECONDARY Severe or Serious Adverse Events |
0; 0 | — |
| SECONDARY Maximal CSF VX-745 Concentration |
0.062 | — |
| SECONDARY Episodic Memory Function |
3.5 | — |
Eligibility Criteria
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 ( 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
Data sourced from ClinicalTrials.gov (NCT02423200). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.