Minocycline in Alzheimer's disease

Not Applicable

Completed

• Conditions: Topic: Dementias and Neurodegenerative Diseases Research Network; Subtopic: Dementia; Disease: Alzheimer's Disease; Nervous System Diseases; Alzheimer disease

• Registration Number: ISRCTN16105064
• Lead Sponsor: King's College London (UK)

Brief Summary

2019 results in: https://www.ncbi.nlm.nih.gov/pubmed/31738372 (added 19/11/2019)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-07-24
• Study Completion: 2018-05-31
• Last Update Posted: 10 December 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 544

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

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/.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
ot provided at time of registration