Cerebral Autosomal Dominant Arteriopathy With Subcortical Infarcts and Leukoencephalopathy (CADASIL) Study

Part of paid clinical trials in Los Angeles, California.

Sponsor
University of Wisconsin, Madison
Study ID
NCT05677880
Status
Recruiting

Conditions

  • CADASIL

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Study Procedures — OTHER
    Participants will experience * Neurocognitive Tests and Self-Report Measures * Clinical Interviews * Neurological Exam * MRI screening at baseline, 18 months, 36 months * Fasted Blood draw

Study Details

This is an observational study to better understand the risk factors and progression of CADASIL, a leading cause of vascular cognitive impairment and dementia (VCID). 575 participants will be enrolled and can expect to be on study for up to 5 years.

Key Dates

Start date
Jun 3, 2022
Status verified
Jan 2026
Primary completion
Jun 30, 2027
Completion
Aug 31, 2027

Study Design

Enrollment
660 participants (estimated)

Arms

  • Arm: Non-Carrier Cohort
    About 100 participants who are at-risk, healthy family members with No NOTCH3 Mutation and no symptoms or signs of cognitive decline.
  • Arm: Pre-Symptomatic NOTCH3 Cohort
    About 133 participants who are pre-symptomatic, at-risk, and healthy (with verified NOTCH3 mutation) family members with no symptoms.
  • Arm: Symptomatic NOTCH3 Cohort - No Functional Decline
    About 134 participants who are symptomatic (with verified NOTCH3 mutation) family members and no functional decline (e.g., mild cognitive impairment (MCI) with premorbid functional levels maintained).
  • Arm: Symptomatic NOTCH3 Cohort - Functional Decline
    About 133 participants who are symptomatic family members with a verified NOTCH3 CADASIL mutation and evidence of functional decline consistent with early dementia.

Primary Outcome Measure

Performance Measured by Change in Cognitive Executive Function Composite Z-Score [ Time Frame: baseline and 36 months ]

Central Contacts

Locations (12)

FacilityCityStateZIPSite coordinators
University of CaliforniaLos AngelesCalifornia90095-
University of CaliforniaSan FranciscoCalifornia94143-
University of ColoradoDenverColorado80204-
Georgia State University Research FoundationAtlantaGeorgia30303-
Loyola UniversityChicagoIllinois60660-
Columbia UniversityNew YorkNew York10027-
Oregon Health & Science UniversityPortlandOregon97239-
Brown UniversityProvidenceRhode Island02912-
University of Texas Health Science CenterHoustonTexas77030-
University of TexasSan AntonioTexas78249-
University of UtahSalt Lake CityUtah84112-
University of WashingtonSeattleWashington98195-

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