Doxycycline And Rifampin for Alzheimer's Disease

Not Applicable

Completed

• Conditions: Alzheimer's disease; Nervous System Diseases

• Registration Number: ISRCTN15039674
• Lead Sponsor: McMaster University (Canada)

Brief Summary

2013 results in: https://www.ncbi.nlm.nih.gov/pubmed/22718435 2019 results in https://pubmed.ncbi.nlm.nih.gov/30909214/ (added 19/08/2020)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2006-10-06
• Study Completion: 2009-11-30
• Last Update Posted: 31 August 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

1. Probable Alzheimer's disease
2. Aged 50 - 99 years old, either sex
3. Standardised Mini Mental State Examination (SMMSE) score 14 to 26 inclusive
4. Consenting patient (or Power of Attorney [POA] consents for patient)
5. Consenting caregiver
6. Sufficient English to complete standardised testing in English
7. May reasonably be expected to complete a one year trial

Exclusion Criteria

1. Other neuro-degenerative diseases such as Lewy body, Parkinson's, fronto-temporal, Huntington's Chorea, Down's Syndrome or Creutzfeld Jacob Disease
2. Cognitive impairment due to acute cerebral trauma, subdural haematoma, injuries from chronic trauma, hypoxic cerebral damage
3. B12 deficiency, cancer or infections e.g. acquired immune deficiency syndrome (AIDS)
4. Endocrine deficiencies
5. Hypercalcemia, hypothyroidism, hyperparathyroidism, Cushing's syndrome, severe renal failure, poorly controlled diabetes mellitus, pituitary disease, etc.
6. Mental retardation
7. Significant cerebrovascular disease or multi-infarct dementia
8. Intra-cranial pathology, tumour or hydrocephalus
9. Co-existing medical conditions such as history of epilepsy or convulsions
10. Clinically significant psychiatric conditions or moderate to severe behavioural disturbances
11. Clinically significant hepatic, renal, pulmonary, metabolic or endocrine diseases
12. History of drug or alcohol abuse
13. History of myasthenia gravis
14. Clinically significant cardiac disease such as cardiac surgery in the past six months, unstable angina or poorly controlled congestive heart failure, uncontrolled hypertension with systolic pressure greater that 180 mmHg or diastolic pressure greater that 110 mmHg
15. Anti-dementia treatments except donepezil, galantamine, rivastigmine, memantine, acetylsalicylic acid (ASA) up to 650 mg OD, Vitamin E 400 i.u., multi B vitamins, Ginko biloba, Cyclooxygenase Type II (Cox II) inhibitors or statins
16. Other investigational drugs
17. Long-term antibiotics
18. Allergy to doxycycline or rifampin

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> 1. Standardised Alzheimer's Disease Assessment Scale - Cognitive Subscale (SADAS-cog), measured at 12 months<br> 2. Clinical Dementia Rating Scale (CDR), measured at 12 months<br>

Secondary Outcome Measures

Name	Time	Method
<br> 1. SMMSE, measured at 12 months<br> 2. AB Cognitive Screen 100 (ABCS 100), measured at 12 months<br> 3. Geriatric Depression Scale (GDS), measured at 12 months<br> 4. Lawton Scale, measured at 12 months<br> 5. Dysfunctional Behaviour Rating Instrument (DBRI), measured at 12 months<br>