Back to results

Measuring Brain Amyloid Plaque Load in Older Adults Using BAY 94-9172

Primary Purpose

Late Onset Alzheimer Disease

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

BAY 94-9172 (Florbetaben)

About this trial

This is an interventional diagnostic trial for Late Onset Alzheimer Disease focused on measuring Alzheimer's disease, Positron emission tomography, Biomarker, Plasma Aβ, Brain amyloid plaque load

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Current Washington Heights-Inwood Community Aging Project (WHICAP) participant Age 65 or older Residing in the community of Washington-Heights/Inwood/Hamilton Heights
Is able to provide informed consent, understand the information provided on the purpose and conduct of the trial and exhibits adequate visual, auditory and communication capabilities to enable compliance with study procedures. This includes performing the psychometric testing and being able to lie down flat in the Positron Emission Tomography (PET) scanner
Possesses a general health that permits adequate compliance with all study procedures.
Informed consent has been signed and dated (with time) by the subject and/or the subject's caregiver (for probable Alzheimer's Disease (AD) patients)

Exclusion Criteria:

Has any contraindication to PET, such as claustrophobia, or inability to lie flat for half an hour as determined by the onsite radiologist performing the scan
Current, past, or anticipated exposure to radiation, which may include being badged for radiation exposure in the workplace or participation in nuclear medicine procedures, including research protocols in the last year
Significant active physical illness particularly those that may affect the brain including blood dyscrasias, lymphomas, hypersplenism, endocrinopathies, renal failure or chronic obstructive lung disease, autonomic neuropathies, peripheral vascular disease, low hemoglobin and malignancy
Scheduled for surgery and/or another invasive procedure within the time period of up to 24 hours following scan
Allergic to the tracer or any of its constituents and/or has a history of severe allergic reactions to drugs or allergens (e.g. patients with allergic asthma)
Critically ill and/or medically unstable and whose clinical course within the observation period is unpredictable, e.g. participants with 14 days of myocardial infarction or stroke, unstable participants with previous surgery (within 7 days), participants with advanced heart insufficiency (New York Heart Association (NYHA) stage IV), or participants with acute renal failure.
Has received any contrast material (X-ray, Magnetic Resonance Imaging (MRI)), or radiopharmaceuticals within 48 hours prior to the application of the Investigational Medicinal Product (IMP) or for whom application of such a substance is planned for 24 hours following IMP administration

Sites / Locations

Columbia University Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

BAY 94-9172

Arm Description

BAY 94-9172 PET/CT

Outcomes

Primary Outcome Measures

Changes in amyloid plaque load in the brain of the course of 3 years

Positron emission tomography (PET) and x-ray computed tomography (CT) brain imaging using Florbetaben is considered an in vivo measure of brain amyloid plaque load. We will obtain PET/CT scans on a selection of participants who will be selected on the basis of change in plasma levels of amyloid beta to validate amyloid beta as a viable biomarker for late onset Alzheimer's disease. Participants will receive scans in a 2010-2012 assessment wave, and then again in a 2014-2015 assessment wave to determine whether increased uptake in the brain correlates with declining levels of plasma amyloid beta

Secondary Outcome Measures

Full Information

NCT ID

NCT01222351

First Posted

October 14, 2010

Last Updated

August 10, 2023

Sponsor

New York State Psychiatric Institute

Collaborators

Bayer, National Institute on Aging (NIA)

1. Study Identification

Unique Protocol Identification Number

NCT01222351

Brief Title

Measuring Brain Amyloid Plaque Load in Older Adults Using BAY 94-9172

Official Title

BAY 94-9172 PET/CT in Cognitively Normal Older Adults, Older Adults With Mild Cognitive Impairment, and Older Adults With Alzheimer's Disease

Study Type

Interventional

2. Study Status

Record Verification Date

August 2023

Overall Recruitment Status

Completed

Study Start Date

December 2010 (Actual)

Primary Completion Date

October 22, 2014 (Actual)

Study Completion Date

October 22, 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

New York State Psychiatric Institute

Collaborators

Bayer, National Institute on Aging (NIA)

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The overall goal of this project is to establish and validate biomarkers associated with the risk and progression of late onset Alzheimer's disease, mild cognitive impairment and cognitive decline. The investigators will use baseline and longitudinal measurements of plasma amyloid beta-40 and amyloid beta-42 to investigate the risk of developing mild cognitive impairment and late onset Alzheimer's disease, as well as the rates of cognitive decline and Alzheimer's disease progression. Participants will be selected on the basis of change in plasma amyloid beta levels over prior assessment intervals. The purpose of the study is to examine whether brain amyloid plaque load, which will be measured with positron emission tomography and x-ray computed tomography brain imaging using Florbetaben from Bayer, varies as a function of change in plasma levels of amyloid beta. The driving hypothesis of the study is that high plasma levels of amyloid beta are an antecedent indicator of increased risk of cognitive decline, mild cognitive impairment, and incident late onset Alzheimer's disease, and that declining plasma levels of amyloid beta are associated with the onset of cognitive decline. Further, high plasma levels of amyloid beta are related to increased levels of amyloid beta in the brain as measured by positron emission tomography positivity, and the specific pattern of positron emission tomography positivity and a decline in plasma amyloid beta over time are associated with the onset of cognitive decline associated with late onset Alzheimer's disease.

Detailed Description

This project is a sub-study of the Washington Heights-Inwood Community Aging Project, which is a multidisciplinary, epidemiological study of Alzheimer's disease and related neurodegenerative disorders. We will obtain positron emission tomography scans and simultaneous x-ray computed tomography scans using Florbetaben from Bayer on a selection of ongoing participants who will be selected on the basis of change in plasma levels of amyloid beta over time. Approximately 200 participants will receive scans beginning in 2009 and in the 2010-2012 assessment wave and then again in a 2014-2015 assessment wave. Our intention is to examine whether uptake of Florbetaben in the brain varies as a function of previous history of change in plasma levels of amyloid beta in order to validate plasma amyloid beta as a viable biomarker for late onset Alzheimer's disease.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Late Onset Alzheimer Disease

Keywords

Alzheimer's disease, Positron emission tomography, Biomarker, Plasma Aβ, Brain amyloid plaque load

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

161 (Actual)

8. Arms, Groups, and Interventions

Arm Title

BAY 94-9172

Arm Type

Experimental

Arm Description

BAY 94-9172 PET/CT

Intervention Type

Drug

Intervention Name(s)

BAY 94-9172 (Florbetaben)

Other Intervention Name(s)

Florbetaben, Bay 91-9172

Intervention Description

Measure of brain amyloid load using BAY 94-9172 PET/CT

Primary Outcome Measure Information:

Title

Changes in amyloid plaque load in the brain of the course of 3 years

Description

Time Frame

Amyloid plaque load in the brain will be measured at baseline and again 3 years later

10. Eligibility

Sex

All

Minimum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Current Washington Heights-Inwood Community Aging Project (WHICAP) participant Age 65 or older Residing in the community of Washington-Heights/Inwood/Hamilton Heights Is able to provide informed consent, understand the information provided on the purpose and conduct of the trial and exhibits adequate visual, auditory and communication capabilities to enable compliance with study procedures. This includes performing the psychometric testing and being able to lie down flat in the Positron Emission Tomography (PET) scanner Possesses a general health that permits adequate compliance with all study procedures. Informed consent has been signed and dated (with time) by the subject and/or the subject's caregiver (for probable Alzheimer's Disease (AD) patients) Exclusion Criteria: Has any contraindication to PET, such as claustrophobia, or inability to lie flat for half an hour as determined by the onsite radiologist performing the scan Current, past, or anticipated exposure to radiation, which may include being badged for radiation exposure in the workplace or participation in nuclear medicine procedures, including research protocols in the last year Significant active physical illness particularly those that may affect the brain including blood dyscrasias, lymphomas, hypersplenism, endocrinopathies, renal failure or chronic obstructive lung disease, autonomic neuropathies, peripheral vascular disease, low hemoglobin and malignancy Scheduled for surgery and/or another invasive procedure within the time period of up to 24 hours following scan Allergic to the tracer or any of its constituents and/or has a history of severe allergic reactions to drugs or allergens (e.g. patients with allergic asthma) Critically ill and/or medically unstable and whose clinical course within the observation period is unpredictable, e.g. participants with 14 days of myocardial infarction or stroke, unstable participants with previous surgery (within 7 days), participants with advanced heart insufficiency (New York Heart Association (NYHA) stage IV), or participants with acute renal failure. Has received any contrast material (X-ray, Magnetic Resonance Imaging (MRI)), or radiopharmaceuticals within 48 hours prior to the application of the Investigational Medicinal Product (IMP) or for whom application of such a substance is planned for 24 hours following IMP administration

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Richard Mayeux, BS, MD, MSc

Organizational Affiliation

Columbia University

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Yaakov Stern, BA, PhD

Organizational Affiliation

Columbia University

Official's Role

Study Chair

Facility Information:

Facility Name

Columbia University Medical Center

City

New York

State/Province

New York

ZIP/Postal Code

10032

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

20697031

Citation

Cosentino SA, Stern Y, Sokolov E, Scarmeas N, Manly JJ, Tang MX, Schupf N, Mayeux RP. Plasma ss-amyloid and cognitive decline. Arch Neurol. 2010 Dec;67(12):1485-90. doi: 10.1001/archneurol.2010.189. Epub 2010 Aug 9.

Results Reference

background

PubMed Identifier

20205671

Citation

Forsberg A, Almkvist O, Engler H, Wall A, Langstrom B, Nordberg A. High PIB retention in Alzheimer's disease is an early event with complex relationship with CSF biomarkers and functional parameters. Curr Alzheimer Res. 2010 Feb;7(1):56-66. doi: 10.2174/156720510790274446.

Results Reference

background

PubMed Identifier

26221954

Citation

Gu Y, Razlighi QR, Zahodne LB, Janicki SC, Ichise M, Manly JJ, Devanand DP, Brickman AM, Schupf N, Mayeux R, Stern Y. Brain Amyloid Deposition and Longitudinal Cognitive Decline in Nondemented Older Subjects: Results from a Multi-Ethnic Population. PLoS One. 2015 Jul 29;10(7):e0123743. doi: 10.1371/journal.pone.0123743. eCollection 2015.

Results Reference

result

Learn more about this trial

Measuring Brain Amyloid Plaque Load in Older Adults Using BAY 94-9172

We'll reach out to this number within 24 hrs