A Phase 1 interventional study of SPECT scan in Alzheimer Disease, sponsored by Institute for Neurodegenerative Disorders. Terminated at 2 sites in United States. Open to participants aged 50 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2010-10-06.
Sponsored by Institute for Neurodegenerative Disorders · Phase 1, Interventional, and Screening
Purpose:
The main objectives of this proposal are as follows:
To assess the dynamic uptake and washout of 123-I AV151, a potential imaging biomarker for β-amyloid burden in brain, using single photon emission computed tomography (SPECT) in similarly aged healthy controls and Alzheimer's (AD) subjects
To perform blood metabolite characterization of 123-I AV151 in healthy and AD subjects to determine the metabolic fate and nature of metabolites in assessment of 123-I AV151 as a single photon computed tomography (SPECT) brain imaging agent
Evaluate the test/retest reproducibility of 123-I AV151 and SPECT in AD subjects and healthy controls
General Design and Methods. The underlying goal of this study is to assess 123-I AV151 SPECT imaging as a tool to detect ß-amyloid deposition in the brain of AD research participants and age- and gender-matched healthy subjects. All study procedures will be conducted at the Institute for Neurodegenerative Disorders (IND) and Molecular NeuroImaging (MNI) in New Haven, CT. Approximately 20 patients with Alzheimers 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. Informed consent will be obtained for all. All subjects will undergo 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 AV151. Subjects will undergo serial SPECT imaging scans and serial venous plasma sampling for measurement of 123-I AV151 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 AV151. 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.
3,678 studies on the registry are indexed under Alzheimer Disease; 872 are open to participants now.
This study's enrollment of 1 is below the median of 70 across 2,808 interventional studies indexed under Alzheimer Disease.
Browse Alzheimer Disease studies →Institute for Neurodegenerative Disorders is the lead sponsor of 40 studies on the registry; none are open to participants now.
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INCLUSION CRITERIA: ALZHEIMER DISEASE
EXCLUSION CRITERIA: ALZHEIMER DISEASE
Concomitant therapy Patients may remain on a stable dose of anticholinesterase medication during the study. Use of donepezil (Aricept®), rivastigmine (Exelon®), galantamine (Razadyne®), tacrine (Cognex®), and memantine (Namenda®) are permitted during the study. Doses of these compounds must be stable for 2 months prior to the study. At each visit after the screening visit, the investigator will ask the patient whether any medications including OTC medications, were taken since the previous visit.
Use of antipsychotics for agitation and benzodiazepines for insomnia or anxiety is permitted. However, the use of these agents is not permitted within the 8 hours prior to administration of cognitive testing.
INCLUSION CRITERIA: HEALTHY VOLUNTEERS
EXCLUSION CRITERIA: HEALTHY VOLUNEERS
Drug: SPECT scan
AV151-01: Evaluation of \[123I\] AV151 and SPECT as a marker of beta-amyloid protein deposition in subjects with Alzheimer disease in comparison to healthy subjects
AV151-01: Evaluation of [123I] AV151 and SPECT as a marker of beta-amyloid protein deposition in subjects with Alzheimer disease in comparison to healthy subjects
Time frame: 1 year
This study is terminated, as verified in Oct 2010. You cannot join it, but the record below documents what was studied.
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Institute for Neurodegenerative Disorders