Biomarker Study for Alzheimer's Disease

NCT02472899 | Completed

• 1 other identifier: CT4525
• Study Type: observational
• Target: 115
• Locations: 1 country
• Sites: 1

Brief Summary

The study aims to identify immune biomarkers in peripheral blood for identifying Alzheimer's disease (AD). Blood samples from subjects with AD will be compared to age-matched controls without cognitive symptoms, as well as healthy younger subjects.

Conditions

Alzheimer's Disease

Keywords

Geriatrics; Neurocognitive Disorder; Biomarkers; Immunology

Outcome Measures

Primary Outcomes (1)

• Frequency of monoclonal antibodies and of CD4+ and CD25+ T cells

  Up to one year

Study Arms (3)

Alzheimer's Disease

Blood sample from subjects older than 60 years with a clinical diagnosis of Alzheimer's Disease

Other: Blood sample

Older controls

Blood sample from subjects older than 60 years who are cognitively normal

Other: Blood sample

Younger controls

Blood sample from healthy subjects aged 20 to 30 years who are cognitively normal

Other: Blood sample

Interventions

Blood sample OTHER

Non-interventional study based on blood samples taken at a single study visit

Alzheimer's Disease; Older controls; Younger controls

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects will include males and females older than 60 years diagnosed as having clinical AD according to DSM-IV criteria. The control group will comprise cognitively normal community dwelling males and females older than 60 years. In addition, a group of healthy young male and female controls aged 20-30 years will serve as the reference group. The diagnosis of both older patients and controls will be determined independently by a multidisciplinary team of experts at the Memory Clinic of the Beersheva Mental Health Center.

You may qualify if:

• Dementia syndrome resulting from probable Alzheimer's disease

You may not qualify if:

• Dementia syndrome caused by conditions other than Alzheimer's disease

Sponsors & Collaborators

• Beersheva Mental Health Center: lead

Study Sites (1)

Beersheva Mental Health Center

Beersheva, Israel

Location

Related Publications (7)

• Selkoe DJ. Alzheimer's disease: genes, proteins, and therapy. Physiol Rev. 2001 Apr;81(2):741-66. doi: 10.1152/physrev.2001.81.2.741.

  PMID: 11274343 BACKGROUND

• McGeer PL, Rogers J, McGeer EG. Inflammation, anti-inflammatory agents and Alzheimer disease: the last 12 years. J Alzheimers Dis. 2006;9(3 Suppl):271-6. doi: 10.3233/jad-2006-9s330.

  PMID: 16914866 BACKGROUND

• Schenk D, Barbour R, Dunn W, Gordon G, Grajeda H, Guido T, Hu K, Huang J, Johnson-Wood K, Khan K, Kholodenko D, Lee M, Liao Z, Lieberburg I, Motter R, Mutter L, Soriano F, Shopp G, Vasquez N, Vandevert C, Walker S, Wogulis M, Yednock T, Games D, Seubert P. Immunization with amyloid-beta attenuates Alzheimer-disease-like pathology in the PDAPP mouse. Nature. 1999 Jul 8;400(6740):173-7. doi: 10.1038/22124.

  PMID: 10408445 BACKGROUND

• Orgogozo JM, Gilman S, Dartigues JF, Laurent B, Puel M, Kirby LC, Jouanny P, Dubois B, Eisner L, Flitman S, Michel BF, Boada M, Frank A, Hock C. Subacute meningoencephalitis in a subset of patients with AD after Abeta42 immunization. Neurology. 2003 Jul 8;61(1):46-54. doi: 10.1212/01.wnl.0000073623.84147.a8.

  PMID: 12847155 BACKGROUND

• Hock C, Konietzko U, Streffer JR, Tracy J, Signorell A, Muller-Tillmanns B, Lemke U, Henke K, Moritz E, Garcia E, Wollmer MA, Umbricht D, de Quervain DJ, Hofmann M, Maddalena A, Papassotiropoulos A, Nitsch RM. Antibodies against beta-amyloid slow cognitive decline in Alzheimer's disease. Neuron. 2003 May 22;38(4):547-54. doi: 10.1016/s0896-6273(03)00294-0.

  PMID: 12765607 BACKGROUND

• Monsonego A, Imitola J, Petrovic S, Zota V, Nemirovsky A, Baron R, Fisher Y, Owens T, Weiner HL. Abeta-induced meningoencephalitis is IFN-gamma-dependent and is associated with T cell-dependent clearance of Abeta in a mouse model of Alzheimer's disease. Proc Natl Acad Sci U S A. 2006 Mar 28;103(13):5048-53. doi: 10.1073/pnas.0506209103. Epub 2006 Mar 20.

  PMID: 16549802 BACKGROUND

• Monsonego A, Zota V, Karni A, Krieger JI, Bar-Or A, Bitan G, Budson AE, Sperling R, Selkoe DJ, Weiner HL. Increased T cell reactivity to amyloid beta protein in older humans and patients with Alzheimer disease. J Clin Invest. 2003 Aug;112(3):415-22. doi: 10.1172/JCI18104.

  PMID: 12897209 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Frozen serum

MeSH Terms

Conditions

Alzheimer Disease; Neurocognitive Disorders

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Tzvi Dwolatzky, MD

  Beersheva Mental Health Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: OTHER
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 10, 2015
• First Posted: June 16, 2015
• Study Start: February 1, 2007
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: January 27, 2021

Record last verified: 2021-01

Locations

IL (1)