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Innovative Biomarkers in Alzheimer's Disease and Frontotemporal Dementia (FTD): Preventative and Personalized

This study is not yet open for participant recruitment.
Verified July 2011 by Rambam Health Care Campus
Sponsor:
Information provided by:
Rambam Health Care Campus
ClinicalTrials.gov Identifier:
NCT01403519
First received: July 6, 2011
Last updated: July 26, 2011
Last verified: July 2011
History of Changes
  Purpose

Tau pathology and tangles have been associated with cognitive dysfunction causing neurodegeneration. AD, the most abundant tauopathy is characterized by amyloid plaques and tau tangles. An abundance of tau inclusions, in the absence of amyloid deposits, defines Pick's disease (frontotemporal lobar degeneration), progressive supranuclear palsy (PSP), corticobasal degeneration (CBD) and other diseases including frontal atrophy associated with cognitive clinical dysfunction of frontal dysexecutive syndrome, progressive nonfluent aphasia and semantic dementia as recently reviewed (Gozes 2010). It is the investigators aim to follow other protein expression [as per recent publications (Marksteiner et al., 2011)] in blood and CSF samples from those tauopathies.

Significance: Results should establish the possibility of using tau and other proteins as markers for early detection and disease progression in FTD, also in comparison to Alzheimer's disease (AD).


Condition
Alzheimer's Disease

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Innovative Biomarkers in Alzheimer's Disease and Frontotemporal Dementia (FTD): Preventative and Personalized

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Rambam Health Care Campus:

Biospecimen Retention:   Samples Without DNA

Blood and CSF


Estimated Enrollment: 70
Study Start Date: July 2011
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Alzheimer's disease patients
Patients blood and CSF samples
Control group
Blood and CSF samples
FTD patients
Blood ad CSF samples

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   45 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

We estimate that about 30 patients with Alzheimer's disease, 20 patients with frontotemporal dementia and 20 controls will be included.

Criteria

Inclusion Criteria:

  • Minimal cognitive impairment (MCI) and Alzheimer's disease (AD) patients, men and women, age 45-80 will be asked to participate in the present study.
  • MCI will be diagnosed when on cognitive evaluation the patients will score <1.5 SD on memory tests and will not be demented. AD will be diagnosed according to NINCDS-ADRDA research criteria. Patients will be stratified by age and cognitive (dementia) status. Disease severity for AD: mild to moderate (MMSE >16) AD.
  • Frontotemporal dementia: patients with a clinical diagnosis of frontotemporal dementia [behavioral variants (bv)FTD, progressive nonfluent aphasia (PNFA), or semantic dementia] and the related syndromes corticobasal syndrome (CBS) and progressive supranuclear palsy (PSP) will be included.
  • Inclusion criteria (controls): men and women, ages 45-80, willing to participate in the study and donate a blood samples.

Exclusion Criteria:

  • (patients and controls):

    1. Subjects unable/unwilling to sign an informed consent.
    2. Patients with associated medical condition: alcoholism, immune diseases and end stage medical conditions.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01403519

Locations
Israel
Rambam Hospital Not yet recruiting
Haifa, Israel, 31096
Contact: Judith Aharon-Peretz, M.D.     972-4-8542637     jaharon@rambam.health.gov.il    
Sponsors and Collaborators
Rambam Health Care Campus
Investigators
Principal Investigator: Judith Aharon-Peretz, M.D. Rambam Hospital, Haifa, Israel
Principal Investigator: Illana Gozes, Ph.D. Tel Aviv University, Sackler School of Medicine, Israel
  More Information

Publications:

Responsible Party: Prof' Judith Aharon-Peretz, Rambam Medical Center
ClinicalTrials.gov Identifier: NCT01403519     History of Changes
Other Study ID Numbers: 437-10CTIL
Study First Received: July 6, 2011
Last Updated: July 26, 2011
Health Authority: Israel: Ministry of Health

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Frontotemporal Dementia
Aphasia, Primary Progressive
Pick Disease of the Brain
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
 Frontotemporal Lobar Degeneration
TDP-43 Proteinopathies
Proteostasis Deficiencies
Metabolic Diseases
Aphasia
Speech Disorders
Language Disorders
Communication Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on May 21, 2013