Effects of Doxycycline and Rifampicin on Biomarkers of Alzheimer's Disease in the Cerebrospinal Fluid

• Status: Completed
• Trial end date: 2010-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This study will determine if biomarkers found in the cerebrospinal fluid of people with Alzheimer's disease, are affected by treatment with two common antibiotics, doxycycline and rifampicin, suggesting a disease-modifying effect of those treatments.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hamilton Health Sciences Corporation
• Collaborator: The Physicians' Services Incorporated Foundation
• Treatments: Doxycycline; Rifampin

Criteria

Inclusion Criteria:

• Male or female

• Age greater than or equal to 50 years

• Diagnosis of probable Alzheimer's disease by NINCDS-ADRDA criteria

• Standardized Mini-Mental State Examination score 14-26 inclusive

• A caregiver who consents to monitor study medications, report on patient function, bring the patient to visits, etc.

• Vision, hearing, language ability sufficient to complete standardized testing in English.

• Patient consents (or legal representative consents for patient)

• Generally stable level of health where patient may be reasonably expected to complete a 1 year trial

Exclusion Criteria:

• Other neurodegenerative diseases such as Lewy body or Parkinson's

• Cognitive impairment due to: acute trauma, subdural hematoma, hypoxic cerebral damage, B12 deficiency, infections such as AIDS or meningitis, cerebral neoplasia, endocrine deficiencies, mental retardation

• Significant cerebrovascular disease or multi-infarct dementia

• Intra-cranial pathology such as tumour

• Co-existing medical conditions such as epilepsy, major psychiatric conditions, depression (Cornell Depression in Dementia Scale score of 12 or more), significant liver, kidney, lung, metabolic or endocrine diseases

• Clinically significant cardiac disease such as uncontrolled angina or hypertension

• Anti-dementia treatments other than donepezil, galantamine, rivastigmine, memantine

• Enrollment in trials with other investigational drugs

• Antibiotic use more than one month in the last six months

• Allergy to doxycycline or rifampicin