Alzheimer's Disease Clinical Trial
Official title:
Innovative Biomarkers in Alzheimer's Disease and Frontotemporal Dementia (FTD): Preventative and Personalized
Verified date | July 2011 |
Source | Rambam Health Care Campus |
Contact | n/a |
Is FDA regulated | No |
Health authority | Israel: Ministry of Health |
Study type | Observational |
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).
Status | Not yet recruiting |
Enrollment | 70 |
Est. completion date | January 2014 |
Est. primary completion date | January 2014 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 45 Years to 80 Years |
Eligibility |
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. |
Observational Model: Case Control, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
Israel | Rambam Hospital | Haifa |
Lead Sponsor | Collaborator |
---|---|
Rambam Health Care Campus |
Israel,
de Rock E, Taylor N. An easy method of layering blood over Ficoll-Paque gradients. J Immunol Methods. 1977;17(3-4):373-4. — View Citation
Dresner E, Agam G, Gozes I. Activity-dependent neuroprotective protein (ADNP) expression level is correlated with the expression of the sister protein ADNP2: deregulation in schizophrenia. Eur Neuropsychopharmacol. 2011 May;21(5):355-61. doi: 10.1016/j.euroneuro.2010.06.004. Epub 2010 Jul 3. — View Citation
Gozes I. Tau pathology and future therapeutics. Curr Alzheimer Res. 2010 Dec;7(8):685-96. Review. — View Citation
Kozlovsky N, Regenold WT, Levine J, Rapoport A, Belmaker RH, Agam G. GSK-3beta in cerebrospinal fluid of schizophrenia patients. J Neural Transm (Vienna). 2004 Aug;111(8):1093-8. Epub 2004 Apr 27. — View Citation
Marksteiner J, Kemmler G, Weiss EM, Knaus G, Ullrich C, Mechtcheriakov S, Oberbauer H, Auffinger S, Hinterhölzl J, Hinterhuber H, Humpel C. Five out of 16 plasma signaling proteins are enhanced in plasma of patients with mild cognitive impairment and Alzheimer's disease. Neurobiol Aging. 2011 Mar;32(3):539-40. doi: 10.1016/j.neurobiolaging.2009.03.011. Epub 2009 Apr 22. — View Citation
McCauley I, Hartmann PE. The estimation of B lymphocytes and their subpopulations in pigs. A comparison between a method using whole blood and one using Ficoll-Paque purified mononuclear cells. J Immunol Methods. 1982;50(1):33-8. — View Citation
Shiryaev N, Jouroukhin Y, Gozes I. 3R tau expression modifies behavior in transgenic mice. J Neurosci Res. 2010 Sep;88(12):2727-35. doi: 10.1002/jnr.22431. — View Citation
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