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
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 April 15, 2014