NCT01329523

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2010

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2010

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 10, 2011

Completed
3 months until next milestone

First Posted

Study publicly available on registry

April 6, 2011

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2011

Completed
Last Updated

October 6, 2011

Status Verified

January 1, 2011

Enrollment Period

11 months

First QC Date

January 10, 2011

Last Update Submit

October 4, 2011

Conditions

Dementia

Keywords

DementiaInsulin-like growth factorIGFAPO E4Genetics

Outcome Measures

Primary Outcomes (1)

  • Genetic polymorphisms of insulin-like growth factors

    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.

    Single clinic visit (day 1)

Secondary Outcomes (1)

  • Genetic testing of Apolipoprotein (APO) E4

    Single clinic visit (day 1)

Study Arms (3)

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 Criteria

Age50 Years - 81 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Avera Research Institute

Sioux Falls, South Dakota, 57105, United States

Location

Related Publications (5)

  • 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.

    PMID: 16131630BACKGROUND

  • 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.

    PMID: 19519303BACKGROUND

  • 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.

    PMID: 11720784BACKGROUND

  • 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.

    PMID: 12453890BACKGROUND

  • 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.

    PMID: 15201478BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

saliva and blood

MeSH Terms

Conditions

Dementia

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental Disorders

Study Officials

  • Umesh Chakunta, MD

    Avera McKennan Hospital & University Health Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 10, 2011

First Posted

April 6, 2011

Study Start

November 1, 2010

Primary Completion

October 1, 2011

Study Completion

October 1, 2011

Last Updated

October 6, 2011

Record last verified: 2011-01

Locations

US(1)