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NCT Number: NCT01329523

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

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.

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Key information

Conditions

Dementia Brain Diseases Central Nervous System Diseases Mental Disorders Nervous System Diseases Neurocognitive Disorders

Age range

50 year–81 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Avera Research Institute

Sioux Falls, South Dakota, 57105, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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 outcomes

  1. 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.

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Sponsors and collaborators

Lead sponsor

Avera McKennan Hospital & University Health Center

Other

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Apr 6, 2011
Registry last updated
Oct 6, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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