Amyloid imaging in Alzheimer’s disease, frontotemporal dementia and healthy volunteers
- Conditions
- se of 18F-AV-45 positron emission tomography as early diagnostic technique in frontal lobe dementia and Alzheimer's disease.MedDRA version: 14.0 Level: PT Classification code 10061816 Term: Diagnostic procedure System Organ Class: 10022891 - Investigations
- Registration Number
- EUCTR2008-003597-18-GB
- Lead Sponsor
- Avid Radiopharmaceuticals, Inc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 34
Patients may be enrolled in the probable AD group if they:
• Are at least 50 years old (male or female);
•Subjects whose history of cognitive decline has been gradual in onset and progressive over a period of at least 6 months.
• Meet the National Institute of Neurological and Communication Disorders and Stroke (NINCDS) criteria for probable AD and have a Mimi Mental State Examination (MMSE) score at screening between 10 and 24 inclusive;
• Have a caregiver who can report on their mental status and activities of daily living (ADL); and
• Give informed consent. If the patient is incapable of giving informed consent, the caregiver may consent on behalf of the patients (the patient must still confirm assent).
Patients may be enrolled in the FTD group if they;
• Are at least 45 years old (male or female);
• Meet the consensus criteria for FTD (Neary, Snowden et al., 2005) and have mild to moderate disease with the clinical phenotype of behavioural-disexecutive FTD;
• Have a caregiver who can report on their mental status and ADL; and
• Give informed consent. If the patient is incapable of giving informed consent, the caregiver may consent on behalf of the patients (the patient must still confirm assent).
Subjects may be enrolled in the cognitively normal volunteer group if they:
• Are at least 45 years old (male or female);
• Have an MMSE score = 29 and are cognitively normal by informant report and on the psychometric test battery at screening; and
• Give informed consent.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 40
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 40
• History of or current clinically significant neurological disease other then AD or FTD;
• Previous or current diagnosis of other dementing/neurodegenerative disease (Parkinson’s disease, dementia with Lewy bodies, Lewy body variant AD etc);
• Previous or current diagnosis of mixed dementia;
• Evidence (eg MRI, other biomarkers) suggesting dementia other than AD or FTD (or in cognitively normal volunteers any suggestion of AD or FTD) or other neurological pathology (eg stroke, head trauma etc);
• Current clinically significant cardiovascular disease or abnormalities on screening ECG;
• Current clinically significant psychiatric disease;
• Current clinically significant endocrine or metabolic disease, pulmonary, renal or hepatic impairment or cancer;
•Clinical significant infectious disease;
•Recent history of alcohol or substance abuse or dependence;
•Women of childbearing potential who are not surgically sterile or are not refraining from sexual activity while not using reliable methods of contraception;
•Require medicines with narrow therapeutic window;
•Previous participation in a study with amyloid targeting agent;
•Radiopharmaceutical imaging or treatment within 7 days of the day of imaging.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Secondary Objective: ;<br> Primary end point(s): evaluation of FDG PET imaging<br> <br> evaluation of amyloid imaging<br> ;<br> Main Objective: 1. To compare amyloid pathology as determined by 18F-AV-45 positron emission tomography (PET) in patients with frontal temporal dementia (FTD) vs. Alzheimer's disease (AD);<br> 2. To expand the database of 18-F-AV-45 PET imaging in cognitively normal volunteers;<br> 3. To expand the database of 18F-AV-45 PET imaging in AD and FTD patients to determine if 18F-AV-45 PET imaging yields the expected prevalence of AB positivity in clinically defined AD and FTD patients, based on historical autopsy data:<br> 4. To determine the relationship between 18F-AV-45 in-vivo kinetics, cortical atrophy and metabolic impairment in FTD.<br>
- Secondary Outcome Measures
Name Time Method