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

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

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.

Study Overview

• Status: Completed
• Conditions: Dementia

• Study Type: Observational
• Enrollment (Actual): 50

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 81 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Genetic polymorphisms of insulin-like growth factors	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.	Single clinic visit (day 1)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Genetic testing of Apolipoprotein (APO) E4	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.	Single clinic visit (day 1)

Collaborators and Investigators

• Sponsor: Avera McKennan Hospital & University Health Center
• Investigators: Principal Investigator: Umesh Chakunta, MD, Avera McKennan Hospital & University Health Center

Publications and helpful links

General 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. doi: 10.1210/er.2004-0024. Epub 2005 Aug 30.
• 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. doi: 10.2174/156720509788486527.
• 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. doi: 10.1016/s0306-4522(01)00378-5.
• 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. doi: 10.2337/diabetes.51.12.3384.
• 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. doi: 10.3233/jad-2004-6304.

Study record dates

Study Major Dates

• Study Start: November 1, 2010
• Primary Completion (ACTUAL): October 1, 2011
• Study Completion (ACTUAL): October 1, 2011

Study Registration Dates

• First Submitted: January 10, 2011
• First Submitted That Met QC Criteria: April 4, 2011
• First Posted (ESTIMATE): April 6, 2011

Study Record Updates

• Last Update Posted (ESTIMATE): October 6, 2011
• Last Update Submitted That Met QC Criteria: October 4, 2011
• Last Verified: January 1, 2011

More Information

Terms related to this study

• Keywords: Genetics; Dementia; IGF; Insulin-like growth factor; APO E4
• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Dementia
• Other Study ID Numbers: AIHBG-1370-IGF