Frontotemporal Dementia Trial of Nimodipine

  • Study Director: Adam Boxer, MD, PhD
  • Sponsor: UCSF (funded by The Bluefield Project to Cure FTD)
  • Recruiting? No
  • Official Study Title: An Open Label Dose Finding Study of Nimodipine for the Treatment of Progranulin Insufficiency from GRN Gene Mutations
  • ClinicalTrials.gov Identifier: NCT01835665
  • Conditions Studied: Symptomatic and asymptomatic progranulin mutation carriers
  • Intervention: Nimodipine will be administered orally. The dose will be increased weekly for four weeks then maintained for four weeks at the highest tolerated dose, followed by a one-week taper. Nimodipine is FDA approved for treatment in subarachnoid hemorrhage patients.
  • Phase: Phase 1

Purpose of the Study

The purpose of this study is to determine the maximum tolerated dose of nimodipine as well as the safety and tolerability of oral nimodipine in progranulin mutation carriers.

Eligibility

Inclusion Criteria:  Subjects must be 30 years of age (inclusive) or older and be a GRN mutation carrier (gene carrier status known). Subjects must be symptomatic and meet criteria for FTD, CBS or PPA, or be asymptomatic. Subjects must also have a Mini Mental State Examination (MMSE) score of greater than 10 (inclusive) at the screening visit. Subjects must be willing and able to have two brain MRIs as well as two lumbar punctures performed.

Exclusion Criteria: Subjects must not have hypersensitivity or other contraindication to nimodipine use. Subjects must not have a systemic autoimmune disease that might alter progranulin levels. Subjects must not have a history of significant cardiac illness, cancer within five years (other than basal cell of skin), peptic ulcer, gout or poorly controlled diabetes, alcohol or substance abuse within one year prior to screening, and be pregnant (or plan to become pregnant during the course of the study). Subjects must not have previous exposure to nimodipine within four weeks prior to the start of the trial, must not be taking calcium channel antagonists, blood thinners (e.g. clopidogrel, warfarin), or statin medication in combination with niacin (within four weeks of starting trial), must not be using systemic corticosteroids or other anti-inflammatory medication (except NSAID), and must not have been treated with another investigational drug within 30 days of screening.

What to Expect

Testing: Two brain MRIs, two lumbar punctures, neurological and physical examinations, cognitive testing and neuropsychiatric assessments, ECGs, blood and urine specimen collection, vital signs

The Frequency of Visits:

  • Up to 35 days for screening period
  • 4 visits to UCSF: Screening, Baseline (Week 1), Week 5, and Week 8
  • 4 visits to local primary care provider’s office for EKG and vital sign measurements (Week 2, Week 3, Week 4 and Week 10)

Materials Needed Before Evaluation: GRN mutation carrier (gene carrier status must be known)

Costs: No costs will be charged for any of the study procedures. Parking will be validated at UCSF public garages for all study visits.

Contact Information

Clinical Trials Nurse: Mary Koestler, RN, PhD, CCRC – Mary.Koestler@ucsf.edu, 415.476.0661