ICTRP Search Portal

Main

Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	ClinicalTrials.gov
Last refreshed on:	19 February 2015
Main ID:	NCT00970333
Date of registration:	31/08/2009
Prospective Registration:	No
Primary sponsor:	Institute for Neurodegenerative Disorders
Public title:	Evaluation of [18F] FEPPA and PET Imaging as a Marker of Inflammation in Subjects With Neurological Conditions
Scientific title:	Evaluation of [18F] FEPPA and PET as a Marker of Inflammation in Subjects With Neurological Conditions
Date of first enrolment:	August 2009
Target sample size:	3
Recruitment status:	Completed
URL:	http://clinicaltrials.gov/show/NCT00970333
Study type:	Interventional
Study design:	Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Phase:	Phase 1

Countries of recruitment
United States

Contacts

Name:	Danna Jennings, MD
Address:
Telephone:
Email:
Affiliation:	Institute for Neurodegenerative Disorders

Key inclusion & exclusion criteria

Inclusion Criteria:

- Alzheimer's disease patients will be recruited for this study. The following criteria
will be met for inclusion of AD subjects in this study:

- The participant is 50 years or older.

- Written informed consent is obtained.

- Participants have a clinical diagnosis of probable Alzheimer's disease based on
National Institute of Neurological and Communicative Disorders and
Stroke/Alzheimer's Disease and Related Disorders Association (NINCDS/ADRDA)
criteria.

- Clinical Dementia Rating Scale score = 2.

- Modified Hachinski Ischemia Scale score of = 4.

- For females, non-child bearing potential or a negative urine or blood pregnancy
test on day of [18F]-FEPPA injection.

Exclusion Criteria:

- Alzheimer's subjects will be excluded from participation for the following reasons:

- The subject has a history of significant cerebrovascular disease.

- The subject has a clinically significant abnormal laboratory value and/or
clinically significant unstable medical or psychiatric illness

- The subject has evidence of clinically significant gastrointestinal,
cardiovascular, hepatic, renal, hematological, neoplastic, endocrine,
neurological, immunodeficiency, pulmonary, or other disorder or disease.

- Pregnancy

Inclusion Criteria:

- The following criteria will be met for inclusion of PD subjects in this study:

- The participant is 30 years or older.

- Written informed consent is obtained.

- Participants have a clinical diagnosis of Parkinson disease (at least two of the
three cardinal symptoms: resting tremor, rigidity, bradykinesia).

- Hoehn and Yahr =4.

- For females, non-child bearing potential or a negative urine or blood pregnancy
test on day of [18F]-FEPPA injection.

Exclusion Criteria:

- Parkinson's subjects will be excluded from participation for the following reasons:

- The subject has a clinically significant abnormal laboratory value and/or
clinically significant unstable medical or psychiatric illness

- The subject has evidence of clinically significant gastrointestinal,
cardiovascular, hepatic, renal, hematological, neoplastic, endocrine,
neurological, immunodeficiency, pulmonary, or other disorder or disease.

- Pregnancy

Inclusion Criteria:

- Multiple Sclerosis Subject Selection. Subjects who have a clinical diagnosis of
Multiple Sclerosis (MS) will be recruited for this study. The following criteria will
be met for inclusion of MS subjects in this study:

- The participant is 18 years or older.

- Written informed consent is obtained.

- Participants have a clinical diagnosis of Multiple Sclerosis (per the 2005
Revised McDonald Criteria; Polman, et al., 2005).

- Kurtzke Expanded Disability Status Scale (EDSS) = 7.5.

- For females, non-child bearing potential or a negative urine or blood pregnancy
test on day of [18F]-FEPPA injection.

Exclusion Criteria:

- MS subjects will be excluded from participation for the following reasons:

- The subject has a clinically significant abnormal laboratory value and/or
clinically significant unstable medical or psychiatric illness

- The subject has evidence of clinically significant gastrointestinal,
cardiovascular, hepatic, renal, hematological, neoplastic, endocrine,
neurological, immunodeficiency, pulmonary, or other disorder or disease.

- Pregnancy

Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Alzheimer Disease

Multiple Sclerosis

Parkinson Disease

Intervention(s)

Drug: [18F]-FEPPA

Primary Outcome(s)

The primary imaging outcome measure will be the brain regional distribution volumes expressed as a brain tissue to plasma ratio of the radioligand, [18F]-FEPPA. [Time Frame: one year]

Secondary Outcome(s)

Secondary ID(s)

FEPPA 001

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

Disclaimer: Trials posted on this search portal are not endorsed by WHO, but are provided as a service to our users. In no event shall the World Health Organization be liable for any damages arising from the use of the information linked to in this section. None of the information obtained through use of the search portal should in any way be used in clinical care without consulting a physician or licensed health professional. WHO is not responsible for the accuracy, completeness and/or use made of the content displayed for any trial record.