A study to assess the effects of two doses of VX-745 in patients with mild cogntitive impairment due to Alzheimer’s disease or mild Alzheimer’s disease

Phase 1

• Conditions: Alzheimer’s disease; MedDRA version: 18.1Level: LLTClassification code 10001896Term: Alzheimer's diseaseSystem Organ Class: 100000004852; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2014-002855-25-NL
• Lead Sponsor: EIP Pharma, LLC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-11-11
• Last Update Posted: 12 December 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

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

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 clinical trial of medicinal product
• Study Design: Not specified