Alzheimer’s disease MedDRA version: 18.1 Level: LLT Classification code 10001896 Term: Alzheimer's disease System Organ Class: 100000004852
Conditions
Interventions
Product Name: VX-745
Product Code: VX-745
Pharmaceutical Form: Capsule
INN or Proposed INN: N/A
CAS Number: 209410-46-8
Current Sponsor code: VX-745
Concentration unit: mg milligram(s)
Concentration t
Sponsors
EIP Pharma, LLC
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 4 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 12
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the effects on amyloid plaque burden of administration of VX-745 for 12-weeks, as assessed by Dynamic 11C-PiB PET amyloid scanning in patients with MCI due to AD or mild AD;Secondary Objective: • To develop a PK/PD model for VX 745 and amyloid plaque burden reduction, if an effect on amyloid plaque burden is observed. • To obtain a preliminary evaluation of the safety and tolerability of VX-745 in patients with MCI or AD • To obtain data on the effects of VX-745 on synaptic function as assessed by Magnetoencephalography (MEG) and resting state functional MRI.;Primary end point(s): • Change from Baseline to Week 12 within each treatment group in quantitative relative cortical uptake of 11C-PiB as assessed by dynamic PET scanning at baseline and at end of treatment • Number and proportion of responders by quantitative dynamic PET scanning within each dose group (response defined as =7% reduction in amyloid plaque load) ;Timepoint(s) of evaluation of this end point: Dynamic PET scanning: Screening (Visit 2), day 84 of treatment period and follow-up visit. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): PK, Mini-Mental State Examination (MMSE), Wechsler Memory Scale (WMS), MEG, resting state fMRI, and safety.;Timepoint(s) of evaluation of this end point: PK: days 14, 28, 56 and 84 of treatment period. MMSE: Screening (Visit 1), days 1, 28, 56 and 84 of treatment perdiod, follow-up visit. WMS & MEG: days 1, 28 and 84 of treatment perdiod, follow-up visit. fMRI: Screening (Visit 2), day 84 of treatment period and follow-up visit. Safety: throughout the study. | — |
Countries
Netherlands
Contacts
Public ContactClinical Trial Operations
Voisin Consulting
Outcome results
None listed