A Study to Compare Genetic Variations of IGF-I and IGF-II - Full Text View

Purpose

The purpose of this study is to determine if insulin-like growth factors (IGF) play a role in the development of dementia, specifically Alzheimer's disease (AD). The study will compare results from genetic testing between patients with AD and two other groups: younger biological family members of the AD patients and individuals without AD matched by age to the AD patients.

Condition
Dementia

Study Type:	Observational
Study Design:	Observational Model: Cohort Time Perspective: Prospective
Official Title:	A Non-Randomized Controlled Cross-Sectional Study to Compare Genetic Variations of IGF-I and IGF-II in Patients With Moderate to Severe Dementia and Younger Family Members, in Relation to Age-Matched Unaffected Controls

Resource links provided by NLM:

MedlinePlus related topics: Dementia Diabetes Medicines Genetic Testing

U.S. FDA Resources

Further study details as provided by Avera McKennan Hospital & University Health Center:

Primary Outcome Measures:

Genetic polymorphisms of insulin-like growth factors [ Time Frame: Single clinic visit (day 1) ] [ Designated as safety issue: No ]
This study consists of a single clinic visit. After subject has completed the informed consent process and meets eligibility criteria, a blood sample and a saliva sample will be collected. Genetic results from this one-time specimen collection will be evaluated and compared with results from participants in the other two study groups. Outcomes will be measured comparatively.

Secondary Outcome Measures:

Genetic testing of Apolipoprotein (APO) E4 [ Time Frame: Single clinic visit (day 1) ] [ Designated as safety issue: No ]
This study consists of a single clinic visit. After subject has completed the informed consent process and meets eligibility criteria, a blood sample and a saliva sample will be collected. Genetic results from this one-time specimen collection will be evaluated and compared with results from participants in the other two study groups. Outcomes will be measured comparatively.

Biospecimen Retention: Samples With DNA

saliva and blood

Enrollment:	50
Study Start Date:	November 2010
Study Completion Date:	October 2011
Primary Completion Date:	October 2011 (Final data collection date for primary outcome measure)

Groups/Cohorts
Subjects with AD Subjects with a diagnosis of dementia
Family Members Younger biological family members of the patients with dementia
Control Group Individuals without dementia matched in age to the patients with a dementia diagnosis

Eligibility

Ages Eligible for Study:	50 Years to 81 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes
Sampling Method:	Non-Probability Sample

Study Population

There are three groups of participants for this research study: one group will consist of individuals diagnosed with dementia; another group will consist of younger biological family members of the patients with dementia; and the third group will consist of individuals without dementia who are matched in age to the patients with dementia.

Criteria

Inclusion Criteria:

Men and women between the ages of 50 and 81 years old who have a diagnosis of dementia
Men and women who are at least 18 years old and are biologically related to the study subject with dementia
Control subjects must not have a diagnosis of dementia and must be matched in age to the study subjects with dementia

Exclusion Criteria:

Biological family members of the dementia patient who are either younger than 17 years of age or older than the patient with dementia
Biological family members with a diagnosis of dementia
Age-matched control subjects with a diagnosis of dementia

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01329523

Locations

United States, South Dakota
Avera Research Institute
Sioux Falls, South Dakota, United States, 57105

Sponsors and Collaborators

Avera McKennan Hospital & University Health Center

Investigators

Principal Investigator:

Umesh Chakunta, MD

Avera McKennan Hospital & University Health Center

More Information

Additional Information:

Avera Research Institute website This link exits the ClinicalTrials.gov site

Publications:

Russo VC, Gluckman PD, Feldman EL, Werther GA. The insulin-like growth factor system and its pleiotropic functions in brain. Endocr Rev. 2005 Dec;26(7):916-43. Epub 2005 Aug 30. Review.

Freude S, Schilbach K, Schubert M. The role of IGF-1 receptor and insulin receptor signaling for the pathogenesis of Alzheimer's disease: from model organisms to human disease. Curr Alzheimer Res. 2009 Jun;6(3):213-23. Review.

Lichtenwalner RJ, Forbes ME, Bennett SA, Lynch CD, Sonntag WE, Riddle DR. Intracerebroventricular infusion of insulin-like growth factor-I ameliorates the age-related decline in hippocampal neurogenesis. Neuroscience. 2001;107(4):603-13.

Bingham EM, Hopkins D, Smith D, Pernet A, Hallett W, Reed L, Marsden PK, Amiel SA. The role of insulin in human brain glucose metabolism: an 18fluoro-deoxyglucose positron emission tomography study. Diabetes. 2002 Dec;51(12):3384-90.

de la Monte SM, Wands JR. Alzheimer-associated neuronal thread protein mediated cell death is linked to impaired insulin signaling. J Alzheimers Dis. 2004 Jun;6(3):231-42. Review.

Responsible Party:	Avera McKennan Hospital & University Health Center
ClinicalTrials.gov Identifier:	NCT01329523 History of Changes
Other Study ID Numbers:	AIHBG-1370-IGF
Study First Received:	January 10, 2011
Last Updated:	October 4, 2011
Health Authority:	United States: Institutional Review Board

Keywords provided by Avera McKennan Hospital & University Health Center:

Dementia
Insulin-like growth factor
IGF
APO E4
Genetics

Additional relevant MeSH terms:

Dementia
Brain Diseases
Central Nervous System Diseases

Nervous System Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on May 19, 2013