DementiaNCT01329523
A Study to Compare Genetic Variations of IGF-I and IGF-II
An observational study of Dementia, run by Avera McKennan Hospital & University Health Center at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 50 to 81 yearsHealthy volunteers can take part
- Conditions the study is for
- Dementia
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2010to Oct 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 81 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Avera Research Institute
Sioux Falls, South Dakota, 57105
About this study
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
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.
- Conditions
- Dementia
- Keywords
- Dementia, Insulin-like growth factor, IGF, APO E4, Genetics
- Medical subject headings
- Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Single clinic visit (day 1)
Secondary outcomes (1)
Genetic testing of Apolipoprotein (APO) E4
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.
Measured: Single clinic visit (day 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2011 (estimated)
- Study startNov 2010
- Primary completionOct 2011
- Study completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for DementiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Avera McKennan Hospital & University Health Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Umesh Chakunta, MD, Principal investigator, Avera McKennan Hospital & University Health Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01329523
- Sponsor's protocol ID
- AIHBG-1370-IGF
- Status last verified
- Jan 2011
- First submitted
- 10 Jan 2011
- Last updated
- 6 Oct 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 16131630Freude 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.
PubMed 19519303Lichtenwalner 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.
PubMed 11720784Bingham 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.
PubMed 12453890de 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.
PubMed 15201478
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01329523
- Acronym / sponsor ID
- AIHBG-1370-IGF
- Conditions
- Dementia
- Keywords
- Dementia, Insulin-like growth factor, IGF, APO E4, Genetics
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Avera McKennan Hospital & University Health CenterUniversity, hospital or other
- Study start
- Nov 2010
- Primary completion
- Oct 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 6 Apr 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 50 to 81 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
Genetic testing of Apolipoprotein (APO) E4
Time frame: Single clinic visit (day 1)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2011.
- Background: PubMed 16131630Russo 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.
- Background: PubMed 19519303Freude 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.
- Background: PubMed 11720784Lichtenwalner 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.
- Background: PubMed 12453890Bingham 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.
- Background: PubMed 15201478de 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Umesh Chakunta, MD principal investigator
Avera McKennan Hospital & University Health Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dementia, run by Avera McKennan Hospital & University Health Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Oct 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Genetic polymorphisms of insulin-like growth factors (time frame: Single clinic visit (day 1)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01329523, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2011.