A Study to Compare Genetic Variations of IGF-I and IGF-II
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| ClinicalTrials.gov Identifier: NCT01329523 |
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Recruitment Status :
Completed
First Posted : April 6, 2011
Last Update Posted : October 6, 2011
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Sponsor:
Avera McKennan Hospital & University Health Center
Information provided by (Responsible Party):
Avera McKennan Hospital & University Health Center
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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.
| Condition or disease |
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| Dementia |
| Study Type : | Observational |
| Actual Enrollment : | 50 participants |
| 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 |
| Study Start Date : | November 2010 |
| Actual Primary Completion Date : | October 2011 |
| Actual Study Completion Date : | October 2011 |
Resource links provided by the National Library of Medicine
| Group/Cohort |
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Subjects with AD
Subjects with a diagnosis of dementia
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Family Members
Younger biological family members of the patients with dementia
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Control Group
Individuals without dementia matched in age to the patients with a dementia diagnosis
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Primary Outcome Measures :
- Genetic polymorphisms of insulin-like growth factors [ Time Frame: Single clinic visit (day 1) ]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) ]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
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| Ages Eligible for Study: | 50 Years to 81 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| 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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 |
Publications:
| Responsible Party: | Avera McKennan Hospital & University Health Center |
| ClinicalTrials.gov Identifier: | NCT01329523 |
| Other Study ID Numbers: |
AIHBG-1370-IGF |
| First Posted: | April 6, 2011 Key Record Dates |
| Last Update Posted: | October 6, 2011 |
| Last Verified: | January 2011 |
Keywords provided by Avera McKennan Hospital & University Health Center:
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Dementia Insulin-like growth factor IGF APO E4 Genetics |
Additional relevant MeSH terms:
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Dementia Brain Diseases Central Nervous System Diseases |
Nervous System Diseases Neurocognitive Disorders Mental Disorders |