Minocycline in Alzheimer’s Disease Efficacy (MADE) Trial

• Register: EUCTR
• Last refreshed on: 28 February 2019
• Main ID: EUCTR2013-000397-30-GB
• Date of registration: 25/06/2013
• Prospective Registration: Yes
• Primary sponsor: King's College London
• Public title: Minocycline in Alzheimer’s Disease Efficacy (MADE) Trial
• Scientific title: Minocycline in Alzheimer's disease efficacy trial:The MADE trial - MADE
• Date of first enrolment: 30/07/2013
• Target sample size: 560
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2013-000397-30
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no Number of treatment arms in the trial: 3
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no

Countries of recruitment

United Kingdom

Contacts

• Name: Robert Howard
• Affiliation: King's College London

• Name: Robert Howard
• Affiliation: King's College London

Key inclusion & exclusion criteria

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.



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]

Alzheimer's Disease
MedDRA version: 18.1 Level: LLT Classification code 10001896 Term: Alzheimer's disease System Organ Class: 100000004852

Intervention(s)

Trade Name: Acnamino MR 100mg capsules
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: minocycline hydrochloride
CAS Number: 13614-98-7
Other descriptive name: MINOCYCLINE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-
Pharmaceutical form of the placebo: Capsule
Route of administration of the placebo: Oral use

Primary Outcome(s)

Primary end point(s): (i) Cognitive function measured by the Standardised Mini-Mental State Examination
(ii) Functional ability measured with the Bristol Activities of Daily Living Scale

Secondary Objective: The secondary objectives of MADE are:
(i) To compare the safety and tolerability of minocycline at doses of 400mg/day and 200mg/day
(ii) To determine whether 400mg/day offer superior neuroprotection to 200mg/day.
(iii) To investigate associated risks of side-effects and serious adverse events.
(iv) To estimate the magnitude of any statistically significant positive treatment effects on cognitive and functional decline and thereby inform the design and powering of a future phase III trial of definitive clinical effectiveness within the NHS.

Main Objective: To determine whether minocycline is superior to placebo in slowing the disease course of early AD, over a 2-year period, measured by reduced rate of decline in:
(i) Cognition.
(ii) Function.

Timepoint(s) of evaluation of this end point: 6, 12, 18 and 24 months

Secondary Outcome(s)

Secondary end point(s): i) Blood monitoring of haematopoetic, renal and hepatic function will be carried out every 6 months
ii)documentation of skin reactions, gastrointestinal and neurological symptoms

Timepoint(s) of evaluation of this end point: i) 6, 12, 18, 24 months
ii) every 3 months

Secondary ID(s)

MADE

Source(s) of Monetary Support

MRC/NIHR Efficacy and Mechanism Evaluation Programme

Secondary Sponsor(s)

South London and Maudsley NHS Foundation Trust

Ethics review

Status: Approved
Approval date:
Contact:

Results

• Results available: Yes
• Date Posted: 12/10/2019
• Date Completed: 16/04/2018
• URL: https://www.clinicaltrialsregister.eu/ctr-search/trial/2013-000397-30/results