Long-Term Extension Study of Intepirdine (RVT-101) in Subjects With Dementia With Lewy Bodies:

Overview

  • Study type

    Interventional
  • Study phase

    II/III
  • Study IDs

  • Describes the nature of a clinical study. Types include:

    • Observational study — observes people and measures outcomes without affecting results.
    • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
    • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
  • During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.

  • Site IRB
    • Jacksonville, Florida: 16-009596
    • Rochester, Minnesota: 16-009596
    NCT ID: NCT02928445
    Sponsor Protocol Number: RVT-101-2002

About this study

This 6-month extension study will provide further information regarding the long-term safety and tolerability of intepirdine (RVT-101) in subjects with Dementia with Lewy bodies (DLB) who have participated in the double-blind, placebo-controlled, lead-in study RVT-101-2001.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.

See eligibility criteria

Enrolling by invitation

Inclusion Criteria:

  • Participated in the lead-in study RVT-101-2001.

Exclusion Criteria:

  • Any clinically relevant concomitant disease, which, in the opinion of the Investigator, makes the subject unsuitable for inclusion in the study.

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Jacksonville, Fla.

Mayo Clinic principal investigator

Neill Graff-Radford, M.D.

Closed-enrolling by invitation

What is this? (?)
"Close"
Not open to everyone who meets the eligibility criteria, but only those invited to participate by the study team.

Contact information:

Memory Disorder Clinic

(904) 953-2677

Rochester, Minn.

Mayo Clinic principal investigator

Neill Graff-Radford, M.D.

Closed for enrollment

Contact information:

Alzheimer’s Disease Research Center

(507) 284-1324