Recruiting
Phase 3

Observational Study

Sponsor:

McMaster University

Code:

NCT00715858

Conditions

Alzheimer's Disease

Eligibility Criteria

Sex: All

Age: 50+

Healthy Volunteers: Accepted

Interventions

doxycycline

rifampin

placebo

Study Details

Brief summary:

The purpose of this study is to examine the cerebrospinal fluid (CSF) of patients with Alzheimer's disease for biomarkers of inflammation and their response to the antibiotics doxycycline and rifampin. The results of this preliminary analysis will be used in defining the direction of further research.

Conditions

Alzheimer's Disease

Study ID

NCT00715858

Start date

May, 2008

Status verified date

Feb, 2009

Completion date

Oct, 2009

Anticipated

Primary completion date

Aug, 2009

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 50+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Giving informed consent to lumbar puncture
  • Participation in the DARAD clinical trial which requires the following:
  • diagnosis of probable Alzheimer's disease
  • SMMSE 14-26 inclusive
  • community-dwelling
  • age 50 or greater
  • caregiver to monitor study medication and report on ADLs, behaviour, etc.
  • adequate English literacy to complete neuropsychological testing
  • generally stable level of health

Exclusion Criteria:

  • Contraindication to lumbar puncture
  • DARAD exclusion criteria as follows:
  • dementia due to other neurodegenerative diseases
  • cognitive impairment due to head trauma, etc.
  • stroke or significant cerebrovascular disease
  • clinically significant cardiac disease such as recent MI, uncontrolled hypertension
  • taking other anti-dementia treatments or investigational drugs
  • allergy to doxycycline or rifampin
  • significant psychiatric conditions like depression
  • cancer

Study Design

Enrollment

21 participants

Anticipated

Allocation

Non randomized

Intervention Model

Factorial

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: 1 AD doxycycline + rifampin

Participants with AD allocated to doxycycline 100 mg bid od and rifampin 300 mg od for 12 months

active comparator: 2 AD doxycycline

active comparator: 3 AD rifampin

Participants with AD allocated to rifampin 300 mg od od and placebo matched to doxycycline bid for 12 months

placebo comparator: 4 AD placebo

Participants with AD allocated to placebo matched to doxycycline and placebo matched to rifampin for 12 months

no intervention: 5 Control

Age-matched cognitively healthy participants (untreated)

Interventions

doxycycline

capsule, 100 mg, b.i.d., 12 months

rifampin

capsule, 300 mg, od, 12 months

placebo

placebo matched to rifampin; placebo matched to doxycycline

Primary outcome measure

  • IL-1beta [ Time Frame: baseline and 12 months ]
  • TNF-alpha [ Time Frame: baseline and 12 months ]
  • MCP-1 [ Time Frame: baseline and 12 months ]
  • IL-4 [ Time Frame: baseline and 12 month ]
  • IL-10 [ Time Frame: baseline and 12 months ]

Central Contacts and Locations

Central contacts

D. William Molloy, MB

905-777-3837wmolloy@stpetes.ca

Timothy I Standish, MA

905-777-3837tstandish@stpetes.ca

Locations

St.Peter's Hospital

Recruiting

Hamilton, Ontario, Canada, L8M1W9

Principal Investigator:

D. William Molloy, MB

More Information

Sponsor

McMaster University

Last update posted

Feb 4, 2009

Last verified

Feb, 2009

Keywords

  • Alzheimer's disease
  • dementia
  • inflammation
  • cytokine
  • biomarker
  • cerebrospinal fluid
  • serum
  • doxycycline
  • rifampin

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by McMaster University on 2009-02-04.