Topic: Dementias and Neurodegenerative Diseases Research Network
Conditions
Interventions
Drug Treatment. Participants will be allocated to one of three treatment arms:
1. Minocycline 400mg/day
2. Minocycline 200mg/day
3. Placebo
Sponsors
King's College London (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
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/.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Not provided at time of registration | — |
Countries
United Kingdom
Outcome results
None listed