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Research
Introduction
MAC Research
ADRC Research
Autopsy Program
Healthy Volunteering
Investigator Requests
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UCJD (Creutzfeldt-Jakob disease) Quinacrine Study
| Study Director |
Michael Geschwind, MD, PhD
(PIs: Bruce Miller, MD and Stanley Prusiner, MD) |
| Sponsor |
National Institute on Aging |
| Recruiting? |
Yes |
| Official Study Title |
Novel Therapeutics for Prion Diseases: A Randomized, Double-Blinded,
Placebo-Controlled Study of the Efficacy of Quinacrine in the Treatment of Sporadic
Creutzfeldt-Jakob Disease |
| Conditions Studied |
Sporadic Creutzfeldt-Jakob disease (sCJD) |
| Intervention |
Quinacrine. Recent results from experiments show that, at
physiological concentrations, the anti-malarial drug quinacrine permanently clears abnormal
prion proteins from cell culture. |
| Purpose |
The Quinacrine Study is trying determine the efficacy of the
medication quinacrine on survival in sporadic CJD (sCJD). This will be accomplished by bringing
approximately 60 patients with probable or definite sCJD to UCSF for treatment study of
quinacrine. Each patient will have a 50:50 chance of being placed on quinacrine or placebo upon
study enrollment; however, all patients will be offered quinacrine after two months.
Participants will come to UCSF for initial evaluation, potential study enrollment and, if
possible, return to UCSF for follow-up at two, six, and twelve months. |
| Eligibility |
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| Inclusion Criteria |
Diagnosis of probable or definite sCJD: Definite--biopsy confirmed
sCJD; Probable--a progressive dementia with either a typical EEG or a typical MRI consistent
with sCJD, and at least two of the following clinical features:
myoclonus, pyramidal or extrapyramidal signs, visual symptoms, cerebellar signs,
akinetic mutism, other focal higher cortical neurologic signs (e.g. neglect,
apraxia, aphasia). 18 years of age or older. Able to
swallow. Able to follow simple one-step commands.
Have had a brain MRI within 6 months and an EEG within
3 months ruling out other etiologies such as masses,
strokes, or non-convulsive status epilepticus. Consent
to autopsy in the event of their death during or after the study. |
| Exclusion Criteria |
History of other significant or life-threatening disease, including:
cancer; end-stage liver or renal disease; severe heart
disease. History of other disease requiring regular
supportive care. Liver disease. Active alcoholism.
Bone marrow suppression. Severe hypotension. Severe
psoriasis. Poorly controlled diabetes. Women who are
pregnant or breast-feeding. Men, or women of childbearing
age, not practicing reliable contraception. Serious
allergies to quinacrine or other acridines. Current
or recent use of quinacrine (within 6 months). < 18
years of age. Any other contraindication to taking
quinacrine. Genetic form of prion disease is identified
prior to study enrollment. Current use of anti-arrhythmics or G6PD (Glucose 6-Phosphate
Dehydrogenase) deficiency. At the Investigator's discretion. |
| What is Involved? |
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| Testing |
Prior to enrollment, you will have undergone medical, neurological
and neuropsychological examinations, your medical history and records (including laboratory tests,
MRIs, EEGs and other electrophysiological studies) will be reviewed. Some of these previous tests
may be performed again during your initial admission, including other tests in our protocol, i.e.,
an eye exam and lumbard puncture, to rule out other possible diseases that may mimic sCJD and for
monitoring purposes. Monthly blood testing is neccesary to measure possible toxicity from the
study drug. Please speak to one of our study coordinators for more details. |
| Frequency of Visits |
4 visits and a caregiver phone call every month to monitor the
patient's status. |
| Contact Information |
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| Coordinator |
Benjamin Raudabaugh |
| Phone |
(415) 476-0670 |
| Materials Needed Prior to Evaluation |
Doctors Note, MRI scan, Medical Records, Physician's Referral CJD
Diagnosis |
| Costs |
The study drug will be provided to you free of charge. You will
not be charged for any study procedures, nor will you incur any charges for the costs of
hospitalization. Travel and meal expenses would also be covered. |
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