Frontotemporal Lobar Degeneration Clinical Trial
Official title:
Investigation of the Dopamine System in Frontotemporal Dementia
Verified date | August 2019 |
Source | Columbia University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study will test the effects of a medication called tolcapone on cognitive, behavioral,
and language problems seen in patients with frontotemporal dementia (FTD). Tolcapone
increases the amount of dopamine, a brain chemical that may be lowered in FTD. The study will
see if tolcapone can improve thinking, behavior, and language in people with FTD and will
look at the effects of the drug on brain activity.
Patients with FTD who are between 40 and 85 years of age may be eligible for this study.
Participants will be seen as outpatients at the Columbia University Medical Center
approximately one a week for 4 weeks. They take tolcapone or a placebo (a look-alike pill
with no active ingredient) during study week 1. During study week 3, those who took placebo
during week 1 now take tolcapone for 1 week and those who took tolcapone now take placebo. In
addition, patients undergo the following tests and procedures:
- Neurological tests to evaluate attention, problem-solving and memory. These tests are
repeated several times during the course of the study.
- Test to look for a gene that affects the amount of dopamine in the brain, using blood
samples collected in a previous study.
- Blood draws four times during the study.
- Functional MRI (fMRI) to learn about changes in brain regions that are involved in
performing tasks. For fMRI, the patient lies on a table that can slide in and out of the
scanner, a narrow metal cylinder surrounded by a magnetic field. The procedure takes
about 60 minutes and is performed four times over the course of the . FMRI involves
taking pictures of the brain during MRI while the subject performs a task so that
changes in the brain that occur during these tasks can be studied.
Status | Completed |
Enrollment | 28 |
Est. completion date | October 2014 |
Est. primary completion date | October 2014 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 40 Years to 85 Years |
Eligibility |
Inclusion Criteria: - Diagnosis of frontotemporal dementia (FTD) - Age 40 to 85 - Assigned durable power of attorney - Caregiver willing and able to accept the responsibilities involved in the study - Mattis Dementia Rating Scale-2 (MDRS2) score less than 132 Exclusion Criteria: - The diagnosis of any other type of dementia besides FTD including Alzheimer's disease, Lewy body dementia, vascular dementia, dementia associated with Parkinson's disease, corticobasal syndrome, and progressive supranuclear palsy. - Known allergy or serious adverse reaction to tolcapone - Active liver disease - Current alcohol abuse - Active substance abuse - Elevated liver function tests - Patient is taking tolcapone or any other catechol-O-methyltransferase (COMT) inhibitor, benserazide, alpha-methyldopa, dobutamine, apomorphine, isoproterenol, an monoamine oxidase inhibitor (MAO-I), or clozapine - Symptomatic cardiovascular disease (e.g., angina, transient ischemic attack (TIA) , syncope) - Uncontrolled hyper- or hypotension - Any other contraindication to tolcapone - Any medication that significantly affects the dopamine system, including stimulants and antipsychotic medications - Pregnant women |
Country | Name | City | State |
---|---|---|---|
United States | Columbia University Medical Center, 622 West 168th Street | New York | New York |
Lead Sponsor | Collaborator |
---|---|
Columbia University | National Institute of Neurological Disorders and Stroke (NINDS) |
United States,
Adler CH, Singer C, O'Brien C, Hauser RA, Lew MF, Marek KL, Dorflinger E, Pedder S, Deptula D, Yoo K. Randomized, placebo-controlled study of tolcapone in patients with fluctuating Parkinson disease treated with levodopa-carbidopa. Tolcapone Fluctuator Study Group III. Arch Neurol. 1998 Aug;55(8):1089-95. — View Citation
Apud JA, Mattay V, Chen J, Kolachana BS, Callicott JH, Rasetti R, Alce G, Iudicello JE, Akbar N, Egan MF, Goldberg TE, Weinberger DR. Tolcapone improves cognition and cortical information processing in normal human subjects. Neuropsychopharmacology. 2007 May;32(5):1011-20. Epub 2006 Oct 25. — View Citation
Baker M, Mackenzie IR, Pickering-Brown SM, Gass J, Rademakers R, Lindholm C, Snowden J, Adamson J, Sadovnick AD, Rollinson S, Cannon A, Dwosh E, Neary D, Melquist S, Richardson A, Dickson D, Berger Z, Eriksen J, Robinson T, Zehr C, Dickey CA, Crook R, McGowan E, Mann D, Boeve B, Feldman H, Hutton M. Mutations in progranulin cause tau-negative frontotemporal dementia linked to chromosome 17. Nature. 2006 Aug 24;442(7105):916-9. Epub 2006 Jul 16. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Reaction time on the most difficult N-back condition that the patients can successfully perform. | To complete over the next 3 years. | ||
Secondary | A difference in the normalized BOLD signal intensity between subjects on placebo vs. tolcapone. | To complete over the next 3 years. |
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