|
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:
|
25 March 2024 |
|
Main ID: |
NCT02707978 |
|
Date of registration:
|
07/04/2015 |
|
Prospective Registration:
|
Yes |
|
Primary sponsor: |
|
|
Public title:
|
F 18 T807 Tau PET Imaging of Frontotemporal Dementia (FTD)
|
|
Scientific title:
|
F 18 T807 Tau PET Imaging of Frontotemporal Dementia |
|
Date of first enrolment:
|
September 30, 2017 |
|
Target sample size:
|
0 |
|
Recruitment status: |
Withdrawn |
|
URL:
|
https://clinicaltrials.gov/ct2/show/NCT02707978 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Diagnostic. Masking: None (Open Label).
|
|
Phase:
|
Phase 2
|
|
|
Countries of recruitment
|
|
United States
| | | | | | | |
|
Contacts
|
|
Name:
|
Tammie Benzinger, MD, PhD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Washington University School of Medicine |
| | |
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
1. Male or female participants, at least 18 years of age.
2. Clinically diagnosed with frontotemporal dementia (FTD), or a carrier of a mutation
known to cause FTD (with or without symptoms); or a normal control.
3. Participant is able and willing to undergo testing (MRI or CT, PET, radioactive tracer
injection, LP; for those unable to undergo an MRI, CT will be used to generate
regions-of-interest).
4. Pre-menopausal women will have a negative a urine pregnancy test within 24 hours of
T807 drug administration.
Exclusion Criteria:
1. Has any condition that, in the Investigator's opinion, could increase risk to the
participant, limit the participant's ability to tolerate the experimental procedures,
or interfere with the collection/analysis of the data (for example, participants with
severe chronic back pain might not be able to lie still during the scanning
procedures).
2. Is deemed likely unable to perform the imaging procedures for any reason.
3. Has a history of Torsades de Pointes or is taking medications known to prolong QT
interval. To determine who will be excluded from this study based on this criterion,
we will review participant's medical history and current medications at time of
screening. Participants will be excluded from the study if any of the following
restricted medications are being taken:
- Disopyramide
- Dofetilide
- Ibutilide
- Procainamide
- Quinidine
- Sotalol
- Bepridil
4. Has hypersensitivity to F 18 T807 or any of its excipients.
5. Contraindications to PET, PET-CT or MR (e.g. electronic medical devices, inability to
lie still for long periods) that make it unsafe for the individual to participate.
6. Severe claustrophobia.
7. Currently pregnant or breast-feeding.
8. For those electing to undergo the optional lumbar puncture: on
anticoagulant of any form prior to lumbar puncture.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
|
|
Health Condition(s) or Problem(s) studied
|
|
Alzheimer Disease
|
|
Intervention(s)
|
|
Drug: F 18 T807
|
|
Primary Outcome(s)
|
|
F 18 T807 Standard Uptake Value Ratios (SUVR) will be correlated with other imaging modalities (MRI, PET amyloid imaging) and cognitive performance.
[Time Frame: 5 years]
|
|
Secondary ID(s)
|
|
IND 123119 Protocol C
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|