Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00448799
Other study ID # AV-83 001
Secondary ID 07-033
Status Completed
Phase Phase 1
First received March 16, 2007
Last updated May 9, 2008
Start date March 2007
Est. completion date March 2008

Study information

Verified date May 2008
Source Molecular NeuroImaging
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

The underlying goal of this study is to assess 123-I AV83 SPECT imaging as a tool to detect ß-amyloid deposition in the brain of AD research participants and age- and gender-matched healthy subjects.


Description:

Approximately 20 patients with Alzheimer's disease (AD) and 10 healthy controls will be recruited to participate in this study. Healthy controls will be examined to ensure that there is no evidence of neurodegenerative changes including cognitive decline.

All subjects will undergo written informed consent and a screening evaluation including baseline clinical laboratory testing, a baseline physical and neurological evaluation and baseline cognitive evaluations.

Subjects will be asked to undergo a bolus injection of 123-I AV83. Subjects will undergo serial SPECT imaging scans and serial venous plasma sampling for measurement of 123-I AV83 in plasma (both protein bound and free) over a period of up to 6 hours.

Subjects may be asked to undergo a second imaging visit between 2 and 6 weeks following the initial imaging visit following similar procedures to the initial imaging visit to evaluate the reproducibility of the imaging measure using this procedure. The imaging analyses will be performed by an image-processing specialist who will remain masked to the procedures employed with each imaging acquisition.

The primary imaging outcome measure will be the brain regional distribution volumes expressed as a brain tissue to plasma ratio of the radioligand, 123-I AV83. Time to the peak uptake and amplitude of the peak uptake will be evaluated for all brain regions and the results for the AD patients and controls will be compared.

For those subjects undergoing repeat imaging visits, the data from the initial scan will be compared to the second scan to determine which offers the reproducibility of the imaging outcome measure.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date March 2008
Est. primary completion date March 2008
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 50 Years and older
Eligibility Inclusion Criteria:

- The participant is 50 years or older.

- Written informed consent is obtained.

- Participants have a clinical diagnosis of Alzheimer's disease based on National Institute of Neurological and Communicative Disorders and Stroke/Alzheimer's Disease and Related Disorders Association (NINCDS/ADRDA) criteria.

- Mini-Mental Status Exam score < 25.

- Modified Hachinski Ischemia Scale score of = 4.

- Geriatric Depression Scales (GDS) = 10.

- For females, non-child bearing potential or negative urine or blood pregnancy test on day of 123-I AV39 injection.

Exclusion Criteria:

- The subject has signs or symptoms of another neurodegenerative disease including Parkinson's disease, diffuse Lewy body dementia, or history of significant cerebrovascular disease.

- The subject has a clinically significant abnormal laboratory value and/or clinically significant unstable medical or psychiatric illness

- The subject has any disorder that may interfere with drug absorption distribution, metabolism, or excretion (including gastrointestinal surgery).

- The subject has evidence of clinically significant gastrointestinal, cardiovascular, hepatic, renal, hematological, neoplastic, endocrine, neurological, immunodeficiency, pulmonary, or other disorder or disease.

- Pregnancy

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic


Related Conditions & MeSH terms


Intervention

Radiation:
[123-I] AV-83 Injection and Imaging Procedures
Evaluation of [123I] AV83 and SPECT as a marker of beta-amyloid protein deposition in subjects with Alzheimer disease in comparison to healthy subjects

Locations

Country Name City State
United States Molecular NeuroImaging New Haven Connecticut

Sponsors (2)

Lead Sponsor Collaborator
Molecular NeuroImaging Institute for Neurodegenerative Disorders

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Assess the dynamic uptake and washout of 123-I AV83 one year
Secondary Blood metabolite characterization of 123-I AV39 in healthy and AD subjects to determine the metabolic fate and nature of metabolites one year
Secondary Evaluate the test/retest reproducibility of 123-IAv83 and SPECT in AD subjects and healthy controls. one year
See also
  Status Clinical Trial Phase
Completed NCT02409082 - Alzheimers Disease and Neuromarkers in Patients With Acute Hip Fractures N/A
Terminated NCT02565511 - A Study of CAD106 and CNP520 Versus Placebo in Participants at Risk for the Onset of Clinical Symptoms of Alzheimer's Disease Phase 2/Phase 3
Completed NCT01993836 - Markers of Alzheimers Disease and Cognitive Outcomes After Perioperative Care Phase 4
Terminated NCT05097131 - An Observational Study of Aducanumab-avwa in Participants With Alzheimer's Disease in the US
Recruiting NCT04639050 - Brainshuttle AD: A Multiple Ascending Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RO7126209 Following Intravenous Infusion in Participants With Prodromal or Mild to Moderate Alzheimer's Disease Phase 1/Phase 2
Terminated NCT06424236 - Dominantly Inherited Alzheimer Network Trial: An Opportunity to Prevent Dementia: A Study of Potential Disease Modifying Treatments in Individuals at Risk for or With a Type of Early Onset Alzheimer's Disease Caused by a Genetic Mutation Phase 2/Phase 3
Active, not recruiting NCT05891496 - A Research Study Looking at the Effect of Semaglutide on the Immune System and Other Biological Processes in People With Alzheimer's Disease Phase 3
Terminated NCT01723488 - A Phase 0, Open Label, Multi-Center, Exploratory and Safety Study of [F-18]T808 Phase 0
Terminated NCT01733355 - A Phase 0, Open Label, Multi-center Exploratory and Safety Study of [F-18]T807 Phase 0
Completed NCT00911690 - Establishment of a Bank of Biospecimens for Future Research on Age-related Cognitive Disorders N/A
Recruiting NCT01479855 - Multiple Nutritional Deficiencies Causing Dementia of the Alzheimer Type N/A
Completed NCT01469351 - Identifying Potential Effects of Liraglutide on Degenerative Changes N/A
Completed NCT00439010 - Use of [123I] AV39 and SPECT Imaging as a Marker of Protein Disposition in Subjects With Alzheimer Disease Compared to Healthy Subjects Phase 1
Recruiting NCT05269394 - Dominantly Inherited Alzheimer Network Trial: An Opportunity to Prevent Dementia. A Study of Potential Disease Modifying Treatments in Individuals With a Type of Early Onset Alzheimer's Disease Caused by a Genetic Mutation (DIAN-TU) Phase 2/Phase 3
Recruiting NCT01760005 - Dominantly Inherited Alzheimer Network Trial: An Opportunity to Prevent Dementia. A Study of Potential Disease Modifying Treatments in Individuals at Risk for or With a Type of Early Onset Alzheimer's Disease Caused by a Genetic Mutation. Master Protocol DIAN-TU-001 Phase 2/Phase 3
Completed NCT04623242 - Dominantly Inherited Alzheimer Network Trial: An Opportunity to Prevent Dementia. A Study of Potential Disease Modifying Treatments in Individuals at Risk for or With a Type of Early Onset Alzheimer's Disease Caused by a Genetic Mutation. Phase 2/Phase 3
Suspended NCT05552157 - A Study of Potential Disease Modifying Treatments in Individuals at Risk for or With a Type of Early Onset AD Caused by a Genetic Mutation Phase 2/Phase 3
Completed NCT04023994 - A Single Ascending Dose Study to Investigate the Safety, Tolerability, Immunogenicity and Pharmacokinetics of Intravenously Administered RO7126209 in Healthy Participants Phase 1
Terminated NCT03131453 - A Study of CNP520 Versus Placebo in Participants at Risk for the Onset of Clinical Symptoms of Alzheimer's Disease Phase 2/Phase 3
Completed NCT01946243 - The Feasibility of Florbetapir Quantitation Phase 4