Phase
Condition
Dementia
Frontotemporal Dementia
Memory Loss
Treatment
DNL593
Placebo
Clinical Study ID
Ages 18-80 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Key Inclusion Criteria:
Part A:
Women of non-childbearing potential (surgically sterilized or post menopausal) ormen, aged ≥18 to ≤ 55 years
BMI of ≥ 18 to ≤ 32 kg/m²
When engaging in sex with a woman of child bearing potential, two forms of birthcontrol are required
Part B:
Women of non-childbearing potential (surgically sterilized or post menopausal) ormen, aged ≥18 to ≤ 80 years. Women who are of childbearing potential but on highlyeffective, low user dependent contraceptive methods will be allowed.
BMI of ≥ 18 to ≤ 32 kg/m²
Have a Clinical Dementia Rating® plus National Alzheimer's Coordinating Centerfrontotemporal lobar degeneration global score ≥ 0.5
Have confirmed granulin (GRN) mutation via genetic testing or historical recordsavailable for review by investigator
When engaging in sex with a woman of child bearing potential, both the maleparticipant and his female partner must use highly effective contraception
Part C:
- All participants who completed Part B of this trial are eligible for an 18-month OLEif the participant has no unresolved clinically significant TEAEs, where continueddosing may represent a risk to participant safety.
Exclusion
Key Exclusion Criteria:
Have any history of clinically significant neurologic, psychiatric, endocrine,pulmonary, cardiovascular, gastrointestinal, hepatic, pancreatic, renal, metabolic,hematologic, immunologic, or allergic disease, or other major disorders
Have a history of malignancy, except fully resected basal cell carcinoma or othermalignancies at low risk of recurrence
Have a clinically significant history of stroke, cognitive impairment due to causesother than FTD, seizure within 5 years of screening, or head trauma with loss ofconsciousness within 2 years of screening
Have a positive serum pregnancy test or are currently lactating or breastfeeding
Study Design
Connect with a study center
University of Antwerp
Antwerp,
BelgiumActive - Recruiting
UZ Leuven
Leuven,
BelgiumSite Not Available
L2IP - Instituto de Pesquisas Clinicas LTDA
Brasília,
BrazilSite Not Available
Hospital de Clinicas de Porto Alegre (HCPA) - PPDS
Porto Alegre,
BrazilActive - Recruiting
Faculdade de Medicina Da Universidade de São Paulo
São Paulo,
BrazilSite Not Available
Hospital Universitario San Ignacio
Bogotá,
ColombiaSite Not Available
Fakultni nemocnice v Motole
Prague,
CzechiaSite Not Available
CHU de Nantes
Nantes,
FranceActive - Recruiting
CHU Rouen
Rouen,
FranceActive - Recruiting
CHU Toulouse
Toulouse,
FranceActive - Recruiting
ASST degli Spedali Civili di Brescia
Brescia,
ItalySite Not Available
Azienda Ospedaliera Universitaria Careggi
Firenze,
ItalyActive - Recruiting
IRCCS Istituto Auxologico Italiano
Milano,
ItalyActive - Recruiting
Azienda Ospedaliera Cardinale G Panico
Tricase,
ItalySite Not Available
Erasmus University Medical Center
Rotterdam,
NetherlandsActive - Recruiting
Hospital de Braga
Braga,
PortugalActive - Recruiting
Hospital Pedro Hispano
Matosinhos,
PortugalSite Not Available
Campus Neurológico Sénior
Torres Vedras,
PortugalSite Not Available
University Clinical Center Nis
Niš,
SerbiaSite Not Available
Hospital Universitario de Donostia
Donostia-San Sebastian, Guipúzcoa 20014
SpainActive - Recruiting
Hospital Universitario de Donostia
San Sebastian-Donosia, Guipúzcoa 20014
SpainSite Not Available
Hospital Clinic de Barcelona
Barcelona, 8036
SpainSite Not Available
Hospital Universitario La Paz
Madrid, 28046
SpainSite Not Available
Hospital Universitario Virgen del Rocio
Sevilla, 41013
SpainActive - Recruiting
Hacettepe University
Ankara,
TurkeySite Not Available
Istanbul University Istanbul Medical Faculty
Istanbul,
TurkeyActive - Recruiting
Ondokuz Mayis University Hospital
Samsun,
TurkeyActive - Recruiting
Dokuz Eylul University Medical Faculty
İzmir,
TurkeySite Not Available
Simbec Orion
Merthyr Tydfil, Wales CF48 4DR
United KingdomCompleted
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania 19104
United StatesActive - Recruiting
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