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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Avera McKennan Hospital & University Health Center
ClinicalTrials.gov Identifier:
NCT01329523
First received: January 10, 2011
Last updated: October 4, 2011
Last verified: January 2011
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
Publications:
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 August 28, 2014