UnknownPhase 3

A Pilot Study of Inflammatory Markers in Alzheimer's Disease

A Pilot Study Comparing Inflammatory Biomarkers in Blood and CSF in Patients With Alzheimer's Disease and Age-Matched Controls

Lead sponsor

McMaster University

Assets

doxycycline / Rifampin

Listed sites

Recruiting sites

Enrollment

estimated

Study population

Alzheimer’s disease

Key I/E criterion

•Alzheimer's disease

Primary endpoints

•IL-1beta•TNF-alpha•MCP-1

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT00715858

Org study IDR07-63

Timeline

Milestones

Study start2008-05 (month precision)

Study first posted2008-07-15estimated

Last update posted2009-02-04estimated

Primary completion2009-08estimated (month precision)

Study completion2009-10estimated (month precision)

Assets

Drug assets

doxycycline Rifampin

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age50 Years

SexAll

Healthy volunteersAccepted

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

Endpoints (6)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.