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Trial record 3 of 12 for:    cbd | Alzheimer Disease

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

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ClinicalTrials.gov Identifier: NCT01403519
Recruitment Status : Unknown
Verified July 2011 by Rambam Health Care Campus.
Recruitment status was:  Not yet recruiting
First Posted : July 27, 2011
Last Update Posted : July 27, 2011
Sponsor:
Information provided by:
Rambam Health Care Campus

Tracking Information
First Submitted Date July 6, 2011
First Posted Date July 27, 2011
Last Update Posted Date July 27, 2011
Study Start Date July 2011
Estimated Primary Completion Date January 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures Not Provided
Original Primary Outcome Measures Not Provided
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Innovative Biomarkers in Alzheimer's Disease and Frontotemporal Dementia (FTD): Preventative and Personalized
Official Title Innovative Biomarkers in Alzheimer's Disease and Frontotemporal Dementia (FTD): Preventative and Personalized
Brief Summary

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).

Detailed Description

Assessing biomarkers in Alzheimer's disease and frontotemporal dementia

  1. Specific Aims

    To enhance the field of biomarker recognition and facilitate preventative and personalized medicine we are now posing the following question, does the Israeli patient population present similar plasma protein profile as described before for other populations (Marksteiner et al., 2011).

    Studies will be carried out by RNA transcript quantification, quantitative real time polymerase chain reaction (blood cells and CSF) and immunochemical detection at the protein level (CSF and serum).

  2. Methods:

Lymphocytes:

Human lymphocytes are isolated from 10 ml of venous blood using the Ficoll Paque method (de Rock and Taylor 1977; McCauley and Hartmann, 1982), for RNA extraction and determinations we shall follow-up the methods described in our manuscripts (Dresner et al., 2011).

Blood plasma and serum will be prepared as outlined in www.peoimmune.com. Protein quantitation will be carried out using the Tri reagent (Sigma) which allows for simultaneous preparation of RNA, DNA and protein and plasma immunodepletion and albumin depletion kits from Sigma.

Protein quantification: this will be carried out on cellular proteins and also on plasma proteins by SDS-polyacrylamide gel electrophoresis, followed by western analysis.

CSF samples will be collected through a spinal needle inserted into the L4-L5 or L3-L4 vertebral space with the subject in the lateral decubitus position. One ml of CSF derived from each patient will be immediately immersed in ice, with subsequent maintenance at -70 degrees C (or in dry ice during shipping) until the time of the assay. Half ml of each CSF sample will be concentrated by lyophilization in a Speed-Vac (Holten, Gydevang, Denmark) to about 0.1ml. CSF protein immunoblotting will be performed using a similar methodology as described above [and see also(Kozlovsky et al., 2004)]. Protein expression will be analyzed by western blots (Shiryaev et al., 2010).

Number of patients:

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

Professor Aharon-Peretz will evaluate patients with suspected Alzheimer's disease and frontotemporal dementia and include patients at various disease stages in a stratified manner (mild, moderate and severe). All patients will have signed an informed consent form, as per Helsinki guidelines. Clinical evaluation will include: physical and neurological evaluation. All patients will be asked to donate 50 ml blood and selected patients will undergo lumber puncture. The lumber puncture will be performed with the neurological work up. Professor Gozes will coordinate the scientific aspect of the study.

Study coordinators:

Scientific: Professor Illana Gozes, PhD, The Lily and Avraham Gildor Chair for the Investigation of Growth Factors; Director, The Adams Super Center for Brain Studies, Tel Aviv University: igozes@post.tau.ac.il Clinical material: Professor Judith Aharon-Peretz, MD, Head of "Cognitive Neurology Unit" Rambam Rambam-Health Care Campus, Haifa, Israel

Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
Blood and CSF
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.
Condition Alzheimer's Disease
Intervention Not Provided
Study Groups/Cohorts
  • Alzheimer's disease patients
    Patients blood and CSF samples
  • Control group
    Blood and CSF samples
  • FTD patients
    Blood ad CSF samples
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: July¬†26,¬†2011)
70
Original Estimated Enrollment Same as current
Estimated Study Completion Date January 2014
Estimated Primary Completion Date January 2014   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 45 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Israel
Removed Location Countries  
 
Administrative Information
NCT Number NCT01403519
Other Study ID Numbers 437-10CTIL
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Prof' Judith Aharon-Peretz, Rambam Medical Center
Study Sponsor Rambam Health Care Campus
Collaborators Not Provided
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
PRS Account Rambam Health Care Campus
Verification Date July 2011