Clinical Pharmacology of p38 MAP Kinase Inhibitor, VX-745, in Mild Cognitive Impairment Due to Alzheimer's Disease (AD) or Mild AD

EIP Pharma

Status and phase

Completed

Phase 2

Conditions

Alzheimer's Disease

Treatments

Drug: VX-745

Study type

Interventional

Funder types

Industry

Identifiers

NCT02423200

EIP14-745-303

Details and patient eligibility

About

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.

Enrollment

16 patients

Sex

All

Ages

60 to 85 years old

Volunteers

No Healthy Volunteers

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