Positron Emission Tomography of Amyloid in Alzheimer's Disease

NCT00205621 | Suspended Phase 1

• 1 other identifier: 2005/90
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

In this study in-vivo quantification of amyloid load will be performed in patients with AD, MCI and normal controls with Positron Emission Tomography. For this the PET tracers \[11C\]PIB and \[18F\]FDDNP will be compared.

Conditions

Alzheimer's Disease

Keywords

Alzheimer's disease; amyloid; PET; PIB; FDDNP

Outcome Measures

Primary Outcomes (1)

• quantification of amyloid binding

Interventions

Positron Emission Tomography DEVICE

Eligibility Criteria

• Age: 60 Years - 80 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical diagnosis of probable Alzheimer's disease (NINCDS-ADRDA criteria)
• Clinical diagnosis of MCI according to the criteria of Petersen
• Age between 60 and 80 years
• Written informed consent of each subject.
• Hb must be \>8 mmol \\ litre at the time of the screening for males and \>7 mmol\\litre for females.
• Weight \>50 kg
• All subjects have to be "wilsbekwaam"

You may not qualify if:

• Any clinical significant abnormality of any clinical laboratory test
• Any subject who has received any investigational medication within 30 days prior to the start of this study, or who is scheduled to receive an investigational drug.
• Major psychiatric or neurological disorder other than AD
• History of AD in first degree relatives (controls only)
• History of alcohol and/or drug abuse (DSM-IV criteria)
• Any sign of cardiovascular disease including ECG
• Claustrophobia
• Mini Mental State Score below 20
• Use of non-steroid anti-inflammatory drugs
• Abnormalities on MRI other than white matter changes or an incidental small lacunar lesion.
• Blood donation within 3 months before the scan day
• Metal objects in or around the body (braces, pacemaker, metal fragments)
• Use of antithrombotics and ASA
• Fall ≤ 6 months or any relevant gait disorder
• Need for elective surgery ≤ 3 months

Sponsors & Collaborators

• Amsterdam UMC, location VUmc: lead

Study Sites (1)

VU University Medical Center

Amsterdam, 1081 HV, Netherlands

Location

MeSH Terms

Conditions

Alzheimer Disease

Interventions

Positron-Emission Tomography

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Tomography, Emission-Computed; Image Interpretation, Computer-Assisted; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Image Enhancement; Photography; Radionuclide Imaging; Tomography; Diagnostic Techniques, Radioisotope

Study Officials

• Bart van Berckel, MD; PhD

  Amsterdam UMC, location VUmc

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 20, 2005
• Study Start: October 1, 2005
• Study Completion: December 1, 2009
• Last Updated: September 8, 2006

Record last verified: 2005-08

Locations

NL (1)