Condition category
Nervous System Diseases
Date applied
24/07/2013
Date assigned
24/07/2013
Last edited
30/07/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Alzheimer’s disease (a mental disorder) is a major public health issue and there is a clear need to discover and develop treatments that can stop or at least delay disease progression. Unfortunately, although we have drug treatments that can reasonably improve some of the symptoms of Alzheimer's disease, we do not yet have treatments that can slow down or stop deterioration. Minocycline is an antibiotic drug that has also been shown to slow down deterioration in some research using animal models. This makes it the most promising drug for treatment that is not currently in trials and it is cheap and well tolerated. This study will find out the effects of two years of minocycline treatment on deterioration in mental processes and activities of daily living in patients with early Alzheimer's disease assessed and managed within NHS Memory Services. If minocycline can be shown to be working well, this would rapidly pave the way for further studies and ultimately the availability of a low cost and safe treatment for this common and devastating condition.

Who can participate?
Any patient aged 50 or over, diagnosed with Alzheimer's disease, can participate in this study.

What does the study involve?
Participants will be randomly allocated to one of three groups: daily treatment with 400 mg minocycline, 200 mg minocycline or a dummy drug (placebo). They will undergo this treatment for two years.

What are the possible benefits and risks of participating?
It is possible that minocycline may slow the rate of progression of disease or reduce symptoms of Alzheimer’s disease, but this cannot be guaranteed. Participation will provide useful information about the disease and minocycline. It is possible that patients may experience side effects from taking the study drug. These side effects may include nausea, diarrhoea and dizziness. Rarely the drug can cause increased sensitivity to sunlight and, very rarely, joint pain. In addition, there is always a risk of unknown side effects occurring.

Where is the study run from?
The study is run across 20 sites in England and Scotland.

When is study starting and how long is it expected to run for?
The study started in June 2013 and will run until 2018.

Who is funding the study?
The study is funded by the National Institute of Health Research (NIHR), UK.

Who is the main contact?
Dr Olga Zubko
olga.zubko@kcl.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Dr Olga Zubko

ORCID ID

Contact details

16 De Crespigny Park
London
SE5 8AF
United Kingdom
olga.zubko@kcl.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

14866

Study information

Scientific title

The MADE Trial: Minocycline in Alzheimer’s Disease Efficacy trial

Acronym

MADE

Study hypothesis

The MADE Trial will examine the effects of two years of minocycline treatment on deterioration in cognitive function and activities of daily living in patients with early Alzheimer's disease assessed and managed within NHS Memory Services. If minocycline can be shown to have efficacy in the trial, this would rapidly pave the way for effectiveness trials and ultimately availability of a low cost and safe treatment for this common and devastating condition.

Ethics approval

London South REC 13//EE/0063

Study design

Randomised; Interventional; Design type: Treatment

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Topic: Dementias and Neurodegenerative Diseases Research Network; Subtopic: Dementia; Disease: Alzheimer's Disease

Intervention

Drug Treatment. Participants will be allocated to one of three treatment arms:
1. Minocycline 400mg/day
2. Minocycline 200mg/day
3. Placebo
They will take the allocated treatment orally for a period of two years.

Intervention type

Drug

Phase

Not Specified

Drug names

Minocycline

Primary outcome measures

To determine whether minocycline is superior to placebo; Timepoint(s): Baseline and 2 years
1. Cognition will be measured using sMMSE
2. Functional ability will be measured using Bristol Activities of Daily Living Scale (BADLS)

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/06/2013

Overall trial end date

31/05/2018

Reason abandoned

Eligibility

Participant inclusion criteria

1. Diagnosis by National Institute on Aging (NIA)/ Alzheimer's Association (AA) criteria of possible or probable Alzheimer's Disease (McKhann et al 2011)
2. Standardized Mini-Mental State Examination (SMMSE) score >23 with no upper limit
3. Consenting to participate
Target Gender: Male & Female; Upper Age Limit 100 no age limit or unit specified ; Lower Age Limit 45 no age limit or unit specified

Participant type

Patient

Age group

Senior

Gender

Both

Target number of participants

Planned Sample Size: 480; UK Sample Size: 480

Participant exclusion criteria

1. Known allergy to tetracycline antibiotics
2. Diagnosis of mild cognitive impairment
3. 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.
4. Pregnancy and lactation.
5. Known chronic kidney disease stages 3-5
6. Lacks capacity to give informed consent
7. Abnormal serum chemistry laboratory value at Screening deemed to be clinically relevant by the investigator. Patients with creatinine clearance < 50 mL/min at Screening, according to the Cockcroft and Gault equation must be excluded.
8. Systemic Lupus Erythromatosis
9. Severe liver disease
10. Participation in another Clinical Trial of an Investigational Medicinal Product (IMP) in the previous 28 days
Contraindications, warnings and special precautions to minocycline use are not described further in the protocol and the investigator should refer to the Summary of Product Characteristics http://emc.medicines.org.uk/.

Recruitment start date

01/06/2013

Recruitment end date

31/05/2018

Locations

Countries of recruitment

United Kingdom

Trial participating centre

16 De Crespigny Park
London
SE5 8AF
United Kingdom

Sponsor information

Organisation

King's College London (UK)

Sponsor details

James Clerk Maxwell Building
57 Waterloo Road
London
SE1 8WA
United Kingdom

Sponsor type

University/education

Website

Funders

Funder type

Government

Funder name

MRC/NIHR Efficacy and Mechanism Evaluation Programme; Grant Codes: 11/47/01

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes