Clinical trial NCT01329523: A Study to Compare Genetic Variations of IGF-I and IGF-II
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dementia
Keywords: Dementia
Insulin-like growth factor
IGF
APO E4
Genetics
Lead sponsor: Avera McKennan Hospital & University Health Center
Sponsor class: OTHER
First posted: 2011-04-06
Enrollment: 50
Sex: ALL
Minimum age (years): 50
Maximum age (years): 81
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief summary: 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.


Eligibility 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

Primary outcomes:
measure: Genetic polymorphisms of insulin-like growth factors
timeFrame: Single clinic visit (day 1)
Secondary outcomes:
measure: Genetic testing of Apolipoprotein (APO) E4
timeFrame: Single clinic visit (day 1)
Other outcomes:
Locations:
city: Sioux Falls
country: United States
facility: Avera Research Institute
state: South Dakota
Study officials:
affiliation: Avera McKennan Hospital & University Health Center
name: Umesh Chakunta, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.