Minocycline in Alzheimer’s Disease Efficacy (MADE) Trial

Phase 1

• Conditions: Alzheimer's Disease; MedDRA version: 18.1 Level: LLT Classification code 10001896 Term: Alzheimer's disease System Organ Class: 100000004852; Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]

• Registration Number: EUCTR2013-000397-30-GB
• Lead Sponsor: King's College London

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-06-25
• Study Completion: 2018-04-16
• Last Update Posted: 28 February 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 544

Inclusion Criteria

• Diagnosis of possible or probable AD by NIA/AA criteria (McKhann et al 2011).
• sMMSE score >23 with no upper limit.
• Giving informed consent to participate.
• Aged 50+
• Participants must have a potential informant who will assist in the administration of the BADLS
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 560
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 560

Exclusion Criteria

• Known allergy to tetracycline antibiotics.
• Female of childbearing potential. Patients must be surgically sterile (hysterectomy, bilateral salpingectomy / oophorectomy) for at least 6 months minimum or have undergone bilateral tubal occlusion / ligation at least 6 months prior or have been post-menopausal for at least 1 year.
• Uncontrolled serious concomitant illness
• Known chronic kidney disease stages 3b-5
• Moderate liver disease (see Child-Pugh for Classification of Severity of Liver Disease)
• Abnormal serum chemistry laboratory value at Screening deemed to be clinically relevant by the investigator.
• Withholds consent for the study team to inform his/her GP
• Systemic Lupus Erythromatosus (SLE).
• Participation in another Clinical Trial of an Investigational Medicinal Product (IMP) in the previous 28 days.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified