Status:
COMPLETED
Effects of Doxycycline and Rifampicin on Biomarkers of Alzheimer's Disease in the Cerebrospinal Fluid
Lead Sponsor:
Hamilton Health Sciences Corporation
Collaborating Sponsors:
The Physicians' Services Incorporated Foundation
Conditions:
Alzheimer's Disease
Eligibility:
All Genders
50+ years
Phase:
PHASE3
Brief 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, suggesti...
Detailed Description
Diagnostic markers in the cerebrospinal fluid (CSF) have become a rapidly growing research field. Potential disease-modifying drugs like the antibiotics rifampicin and doxycycline, highlight the need ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2010
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT00439166
Start Date
February 1 2007
End Date
December 1 2010
Last Update
March 19 2018
Active Locations (1)
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1
St.Peter's Hospital
Hamilton, Ontario, Canada, L8M1W9