Phase 1/2 Clinical Trial of LY3884963 in Patients With Frontotemporal Dementia With Progranulin Mutations (FTD-GRN)

PHASE1/PHASE2RecruitingINTERVENTIONAL
Enrollment

30

Participants

Timeline

Start Date

November 9, 2020

Primary Completion Date

April 30, 2030

Study Completion Date

April 30, 2030

Conditions
Frontotemporal Dementia
Interventions
BIOLOGICAL

LY3884963

Participants will receive a single dose of LY3884963, administered intra cisterna magna

DRUG

Methylprednisolone

IV pulses every 2 weeks in the first 3 months.

DRUG

Optional Sirolimus

At the investigators discretion following steroid tolerability issues, patients may receive a loading dose, followed by maintenance dose, followed by dose tapering; administered as concomitant medication

DRUG

Optional Prednisone

If needed and at the investigator discretion, Oral Prednisone may be added to the immunosuppression regimen

Trial Locations (11)

2050

RECRUITING

Royal Prince Alfred Hospital, Brain & Mind Research Institute, 94 Mallet Street, Camperdown

3000

RECRUITING

UZ Leuven, Neurologie Herestraat 49, Leuven

13386

RECRUITING

AP-HM Hôpital de La Timone, Saint-Pierre

19104

RECRUITING

Hospital of the University of Pennsylvania, 3 West Gates Building, 3400 Spruce Street, Philadelphia

20014

COMPLETED

Hospital Universitario de Donostia, Servicio De Neurologia, Consultas Externas Neurologia, San Sebastian, Guipúzcoa, Donostia / San Sebastian

32806

COMPLETED

PPD Phase 1 Clinic, 100 West Gore Street, Suite 202, Orlando

59000

RECRUITING

Centre Mémoire de Ressources, Lille

75013

RECRUITING

Le Ber, Institut du Cerveau et de la Moelle Epinière, Paris

32751-5669

RECRUITING

k2 Medical Research-Maitland, Maitland

08036

COMPLETED

Hospital Clinic de Barcelona, Villaroel 170 Servicio de Neurología, Barcelona

WC1N 3BG

RECRUITING

University College London,Queen Square, Dementia Research Building, London,, London

Sponsors
All Listed Sponsors
collaborator

Eli Lilly and Company

INDUSTRY

lead

Prevail Therapeutics

INDUSTRY

NCT04408625 - Phase 1/2 Clinical Trial of LY3884963 in Patients With Frontotemporal Dementia With Progranulin Mutations (FTD-GRN) | Biotech Hunter | Biotech Hunter