Alzheimer's disease Nervous System Diseases Alzheimer's disease
Conditions
Interventions
Experimental group 1: Doxycycline 100 mg twice daily (b.i.d.) plus placebo matched to rifampin 300 mg once daily (o.d.) for 12 months
Experimental group 2: Rifampin 300 mg o.d. plus pl
Sponsors
McMaster University (Canada)
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Standardised Alzheimer's Disease Assessment Scale - Cognitive Subscale (SADAS-cog), measured at 12 months 2. Clinical Dementia Rating Scale (CDR), measured at 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. SMMSE, measured at 12 months 2. AB Cognitive Screen 100 (ABCS 100), measured at 12 months 3. Geriatric Depression Scale (GDS), measured at 12 months 4. Lawton Scale, measured at 12 months 5. Dysfunctional Behaviour Rating Instrument (DBRI), measured at 12 months | — |
Countries
Canada
Outcome results
None listed