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| Sponsors and Collaborators: |
Hamilton Health Sciences The Physicians' Services Incorporated Foundation |
|---|---|
| Information provided by: | McMaster University |
| ClinicalTrials.gov Identifier: | NCT00439166 |
Purpose
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.
| Condition | Intervention |
|---|---|
|
Alzheimer's Disease |
Drug: doxycycline Drug: rifampicin |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Double-Blind, Placebo Control, Factorial Assignment |
| Official Title: | Effects of Treatment With Doxycycline and Rifampicin on Biomarkers of Alzheimer's Disease in the Cerebrospinal Fluid |
| Estimated Enrollment: | 100 |
| Study Start Date: | February 2007 |
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 of improved diagnostic accuracy and offer the potential to examine how these treatments may actually exert their clinical effects.
Cerebrospinal fluid biomarkers (the 42 amino acid form of β-amyloid (Aβ), total tau, and phosphorylated tau) have been evaluated in scientific studies. Tau proteins are considered “state” markers, whereas Aβ(1-42) proteins can be used as “stage” markers. These CSF markers have high sensitivity to differentiate early AD from normal aging, depression, alcohol dementia and Parkinson's disease. When these biomarkers are used in combination with a medical history, clinical examination, laboratory tests and brain imaging, the diagnostic accuracy is improved.
Matrix metalloproteinase (MMP) dysregulation is thought to contribute to a variety of pathological conditions such as arthritis, cancer, atherosclerosis, aneurysms, nephritis, tissue ulcers, and fibrosis. In addition, MMP involvement has been demonstrated in the pathogenesis of a variety of CNS disorders, including bacterial and viral disorders, stroke, multiple sclerosis, ALS, and AD.
There is an inflammatory response in AD. This includes complement activation, elevated C-reactive protein (CRP), elevated pro-inflammatory cytokines (including IL-1-β, IL-6, TNF-α, TGF-β, S100-β), chemokine alterations (IL-8, MIP-1-α, MIP-1-β, MCP-1), and microglial.
We are measuring the biochemical markers of Aβ(1-40) and Aβ(1-42), P-tau and T-tau, matrix metalloproteinases (MMP-2, MMP-9), pro-inflammatory cytokines (IL-1beta, TNF-alpha), and anti-inflammatory cytokines (IL-4 and IL-10) at the start and one year after treatment in the multi-centered, randomized, controlled, trial of disease-modifying drugs rifampicin and/or and doxycycline to slow the progress of Alzheimer’s disease by affecting the production of these biomarkers.
Eligibility| Ages Eligible for Study: | 50 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Tim I Standish, MA | (905)777-3837 ext 12442 | tstandish@stpetes.ca |
| Contact: David D Cowan, MD | (905) 573-4804 | cowand@mcmaster.ca |
| Canada, Ontario | |
| St.Peter's Hospital | Recruiting |
| Hamilton, Ontario, Canada, L8M1W9 | |
| Principal Investigator: William Molloy, MB, FRCPC | |
| Study Chair: | William Molloy, MB, FRCPC | McMaster University |
| Principal Investigator: | Tricia KW Woo, MD, FRCPC | McMaster University |
| Principal Investigator: | David D Cowan, MD, FRCPC | McMaster University |
| Principal Investigator: | Brandon M Kucher, PhD | McMaster University |
| Principal Investigator: | Alwin Cunje, MD, PhD | University of Ottawa |
More Information
| Study ID Numbers: | PSI 06-47 |
| Study First Received: | February 20, 2007 |
| Last Updated: | February 27, 2007 |
| ClinicalTrials.gov Identifier: | NCT00439166 History of Changes |
| Health Authority: | Canada: Health Canada |
|
doxycycline rifampicin cerebrospinal fluid |
biomarkers beta amyloid tau |
|
Anti-Infective Agents Alzheimer Disease Central Nervous System Diseases Brain Diseases Neurodegenerative Diseases Cognition Disorders Antimalarials Rifampin |
Anti-Bacterial Agents Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders Antitubercular Agents Dementia Doxycycline Delirium |
|
Anti-Infective Agents Antiprotozoal Agents Molecular Mechanisms of Pharmacological Action Alzheimer Disease Nervous System Diseases Central Nervous System Diseases Enzyme Inhibitors Brain Diseases Neurodegenerative Diseases Pharmacologic Actions Antibiotics, Antitubercular Antimalarials |
Rifampin Anti-Bacterial Agents Antiparasitic Agents Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders Therapeutic Uses Antitubercular Agents Dementia Tauopathies Nucleic Acid Synthesis Inhibitors Doxycycline Leprostatic Agents |
