A Pilot Study of Inflammatory Markers in Alzheimer's Disease

NCT00715858 | Unknown Phase 3

• 1 other identifier: R07-63
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (5)

• IL-1beta

  baseline and 12 months

• TNF-alpha

  baseline and 12 months

• MCP-1

  baseline and 12 months

• IL-4

  baseline and 12 month

• IL-10

  baseline and 12 months

Secondary Outcomes (1)

• Other inflammatory markers.

  Baseline and 12 month

Study Arms (5)

1 AD doxycycline + rifampin

ACTIVE COMPARATOR

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

Drug: doxycycline; Drug: rifampin

2 AD doxycycline

ACTIVE COMPARATOR

Drug: doxycycline; Drug: placebo

3 AD rifampin

ACTIVE COMPARATOR

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

Drug: rifampin; Drug: placebo

4 AD placebo

PLACEBO COMPARATOR

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

Drug: placebo

5 Control

NO INTERVENTION

Age-matched cognitively healthy participants (untreated)

Interventions

doxycycline DRUG

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

Also known as: Apo-doxy

1 AD doxycycline + rifampin; 2 AD doxycycline

rifampin DRUG

capsule, 300 mg, od, 12 months

Also known as: rifampicin, Rofact, Rifadin

1 AD doxycycline + rifampin; 3 AD rifampin

placebo DRUG

placebo matched to rifampin; placebo matched to doxycycline

2 AD doxycycline; 3 AD rifampin; 4 AD placebo

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Contraindication to lumbar puncture
• 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

Sponsors & Collaborators

• McMaster University: lead
• The Physicians' Services Incorporated Foundation: collaborator

Study Sites (1)

St.Peter's Hospital

Hamilton, Ontario, L8M1W9, Canada

RECRUITING

Related Publications (1)

• Loeb MB, Molloy DW, Smieja M, Standish T, Goldsmith CH, Mahony J, Smith S, Borrie M, Decoteau E, Davidson W, McDougall A, Gnarpe J, O'DONNell M, Chernesky M. A randomized, controlled trial of doxycycline and rifampin for patients with Alzheimer's disease. J Am Geriatr Soc. 2004 Mar;52(3):381-7. doi: 10.1111/j.1532-5415.2004.52109.x.

  PMID: 14962152 BACKGROUND

Related Links

• DARAD Study clinical trial registration on ISRCTN15039674. Details provided.

MeSH Terms

Conditions

Alzheimer Disease; Dementia; Inflammation

Interventions

Doxycycline; Rifampin

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Tetracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Rifamycins; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Lactams, Macrocyclic; Macrocyclic Compounds

Study Officials

• D.William Molloy, MB, MRCPI, FRCPC

  McMaster University

  STUDY CHAIR

• Brandon M Kucher, PhD, MD

  McMaster University

  PRINCIPAL INVESTIGATOR

• Shucui Jiang, MD,PhD

  McMaster University

  STUDY DIRECTOR

• Michel P Rathbone, MB, PhD

  McMaster University

  STUDY DIRECTOR

Central Study Contacts

D. William Molloy, MB

CONTACT

905-777-3837; wmolloy@stpetes.ca

Timothy I Standish, MA

CONTACT

905-777-3837; tstandish@stpetes.ca

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 11, 2008
• First Posted: July 15, 2008
• Study Start: May 1, 2008
• Primary Completion: August 1, 2009
• Study Completion: October 1, 2009
• Last Updated: February 4, 2009

Record last verified: 2009-02

Locations

CA (1)