Minocycline in Alzheimer's disease
| ISRCTN | ISRCTN16105064 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN16105064 |
| Secondary identifying numbers | 14866; 11/47/01 |
- Submission date
- 24/07/2013
- Registration date
- 24/07/2013
- Last edited
- 19/11/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nervous System Diseases
Plain English summary of protocol
Background and study aims
Alzheimers 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 Alzheimers 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
Contact information
Scientific
16 De Crespigny Park
London
SE5 8AF
United Kingdom
| olga.zubko@kcl.ac.uk |
Study information
| Study design | Randomised; Interventional; Design type: Treatment |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | The MADE Trial: Minocycline in Alzheimer's Disease Efficacy trial |
| Study acronym | MADE |
| Study objectives | 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(s) | London South REC, ref: 13//EE/0063 |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Minocycline |
| Primary outcome measure | 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 study start date | 01/06/2013 |
| Completion date | 31/05/2018 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Sex | Both |
| Target number of participants | Planned Sample Size: 480; UK Sample Size: 480 |
| Total final enrolment | 544 |
| Key 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 |
| Key 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/. |
| Date of first enrolment | 01/06/2013 |
| Date of final enrolment | 31/05/2018 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
SE5 8AF
United Kingdom
Sponsor information
University/education
James Clerk Maxwell Building
57 Waterloo Road
London
SE1 8WA
England
United Kingdom
"ROR" |
https://ror.org/0220mzb33 |
|---|
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- Medical Research Council (United Kingdom), UK Medical Research Council, MRC
- Location
- United Kingdom
Government organisation / National government
- Alternative name(s)
- NIHR Efficacy and Mechanism Evaluation Programme, EME
- Location
- United Kingdom
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/02/2020 | 19/11/2019 | Yes | No |
Editorial Notes
19/11/2019: The following changes were made to the trial record:
1. Publication reference added.
2. The total final enrolment was added.
10/08/2018: Internal review.
