A study evaluating the imaging characteristics of 18F-AV-45 in patients with frontotemporal dementia compared to patients with Alzheimer's disease and normal controls

Avid Radiopharmaceuticals, Inc0 sites34 target enrollmentApril 14, 2009

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: se of 18F-AV-45 positron emission tomography as early diagnostic technique in frontal lobe dementia and Alzheimer's disease.
Sponsor: Avid Radiopharmaceuticals, Inc
Enrollment: 34
Status: Active, not recruiting
Last Updated: 6 years ago

No summary available.

Registry

who.int

Start Date

April 14, 2009

End Date

January 12, 2013

Last Updated

6 years ago

Study Type

Interventional clinical trial of medicinal product

Sponsor

•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

•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;