Multi-center Development of a Novel Diagnostic Test for Alzheimer's Disease (DTAD Study)
M
Martin Farlow, MD
Primary Investigator
Recruiting
60-90 years
All
Phase
N/A
30 participants needed
1 Location
Overview
We are doing this research to test a new method of diagnosing Alzheimer’s Disease using a blood test and an injection of a diabetes drug called pramlintide. You will receive one dose of this medication at each of two visits. This study is conducted at three medical centers in Indianapolis and Boston.
Who is Eligible
Ages 60-90
Must be able to complete MRI
Cannot have diagnosis of diabetes or use any medication to regulate blood sugar
The purpose of this study is to see if pramlintide, an injectable drug that lowers the level of sugar in the blood, can be used to help diagnose Alzheimer’s disease. We want to see if an injection of pramlintide with two different doses can increase the amount of amyloid-beta peptide (a specific biomarker for Alzheimer’s disease) in the blood, and whether this differs between individuals with and without Alzheimer’s disease
What is Invovled
In-person at the IUH Neuroscience Center
Participants will have 3-4 onsite visits over 3 months
Compensation
Compensation available via payment card for each completed appointment
In-person at the IUH Neuroscience Center
Participants will have 3-4 onsite visits over 3 months
Compensation
Compensation available via payment card for each completed appointment
You will receive $50 for each completed visit to help with travel expenses related to study visits. Payment will be via check approximately 8 weeks after each visit. You will receive complimentary parking at each visit
Eligibility
You may be eligible for this study if you meet the following criteria:
-
Conditions:
healthy,Alzheimer’s disease
-
Age: Between 60 Years - 90 Years
-
Gender: All
Eligibility Criteria
1. Current research subjects at the BU ADC, VA BHS, or IU ADC, which is referring to the cohort studies such as BU ADC (Indiana University Alzheimer's Disease Core (IU ADC) (IRB# 1011003338.
2. A consensus diagnosis of probable AD, amnestic MCI or control.
3. Aged 60-90.
4. BMI of 20-35.
5. Probable AD subjects must be confirmed for positive AD pathology in the CNS.
6. Probable AD subjects must have a designed research proxy signed before they became demented.
2. A consensus diagnosis of probable AD, amnestic MCI or control.
3. Aged 60-90.
4. BMI of 20-35.
5. Probable AD subjects must be confirmed for positive AD pathology in the CNS.
6. Probable AD subjects must have a designed research proxy signed before they became demented.
Exclusion Criteria
1. Diabetes mellitus.
2. Gastroparesis.
3. Use of insulin, pramlintide, other injectable antihyperglycemic agents, such as glucagon like peptide-1 (GLP-1), or oral anti-diabetic products.
4. Unexplained hypoglycemia (glucose less than or equal to 60 mg/dL) or hyperglycemia (glucose greater than or equal to 126 mg/dL) pre-injection (visits 2 and 3)
-glucose will also be checked at visit 1 and the study physician will assess values that meet the exclusion range above to determine whether to proceed with visit 1.
5. History of stroke.
6. Seizures or use of anti-seizure medications.
7. History of brain injury including loss of consciousness.
8. Diagnosed cerebral amyloid angiopathy (CAA).
9. Infection within 1 month.
2. Gastroparesis.
3. Use of insulin, pramlintide, other injectable antihyperglycemic agents, such as glucagon like peptide-1 (GLP-1), or oral anti-diabetic products.
4. Unexplained hypoglycemia (glucose less than or equal to 60 mg/dL) or hyperglycemia (glucose greater than or equal to 126 mg/dL) pre-injection (visits 2 and 3)
-glucose will also be checked at visit 1 and the study physician will assess values that meet the exclusion range above to determine whether to proceed with visit 1.
5. History of stroke.
6. Seizures or use of anti-seizure medications.
7. History of brain injury including loss of consciousness.
8. Diagnosed cerebral amyloid angiopathy (CAA).
9. Infection within 1 month.
Updated on
15 May 2024.
Study ID: 1810054090
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