Amyloid imaging in Alzheimer’s disease, frontotemporal dementia and healthy volunteers

• Register: EUCTR
• Last refreshed on: 10 December 2019
• Main ID: EUCTR2008-003597-18-GB
• Date of registration: 14/04/2009
• Prospective Registration: Yes
• Primary sponsor: Avid Radiopharmaceuticals, Inc
• Public title: Amyloid imaging in Alzheimer’s disease, frontotemporal dementia and healthy volunteers
• Scientific title: 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
• Date of first enrolment: 28/05/2009
• Target sample size: 40
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2008-003597-18
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no; Randomised: Open: Single blind: Double blind: Parallel group: Cross over: Other: If controlled, specify comparator, Other Medicinial Product: Placebo: Other:
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no

Countries of recruitment

United Kingdom

Key inclusion & exclusion criteria

Inclusion criteria:
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

Exclusion criteria:
• 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.



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Use 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

Intervention(s)

Product Name: florbetapir 18F
Product Code: 18F-AV-45
Pharmaceutical Form: Injection
CAS Number: 956103-76-7
Current Sponsor code: 18F-AV-45
Other descriptive name: florbetapir 18F Injection
Concentration unit: MBq/µl megabecquerel(s)/microlitre
Concentration type: not less then
Concentration number: 54-

Primary Outcome(s)

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);
2. To expand the database of 18-F-AV-45 PET imaging in cognitively normal volunteers;
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:
4. To determine the relationship between 18F-AV-45 in-vivo kinetics, cortical atrophy and metabolic impairment in FTD.

Primary end point(s): evaluation of FDG PET imaging

evaluation of amyloid imaging

Secondary Objective:

Secondary ID(s)

ISRCTN58435532

18F-AV-45-010

Source(s) of Monetary Support

Avid Radiopharmaceuticals Inc

Ethics review

Status: Approved
Approval date:
Contact:

Results

• Results available: Yes
• Date Posted: 26/09/2014
• Date Completed: 12/01/2013
• URL: https://www.clinicaltrialsregister.eu/ctr-search/trial/2008-003597-18/results