NCT06731842

Brief Summary

Multi-modal PET tracer study with the aim of studying the time course of regional deposition of tau in brain of subjects with high risk of being carriers of autosomal dominant Alzheimer´s disease and sporadic early onset and late onset Alzheimer´s disease patient (EOAD, LOAD) in tertiary memory clinic cohort in relation to MRI brain changes, plasma biomarker levels and cognitive performance.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
21mo left

Started May 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress71%
May 2022Dec 2027

Study Start

First participant enrolled

May 15, 2022

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

December 9, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 12, 2024

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

December 12, 2024

Status Verified

September 1, 2024

Enrollment Period

5.6 years

First QC Date

December 9, 2024

Last Update Submit

December 9, 2024

Conditions

Alzheimer´s Disease

Outcome Measures

Primary Outcomes (1)

  • PET measurement of regional tau spreading in brain during Alzheimer continuum

    Anaysis of regional deposition of tau in brain

    3 years

Study Arms (1)

TAU PET and MRI investigation

OTHER
Other: 18F-RO948

Interventions

18F-RO948OTHER

Tau PET imaging using the tau PET tracer 18F-RO948 in famial and sporadic Alzheimer´s disease

TAU PET and MRI investigation

Eligibility Criteria

Age30 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • cancer and other serious disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Karolinska institutet NVS

Stockholm, 141 52, Sweden

Location

Study Officials

  • Agneta K NORDBERG, MD PhD

    Karolinska Institutet

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD PhD Professor

Study Record Dates

First Submitted

December 9, 2024

First Posted

December 12, 2024

Study Start

May 15, 2022

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2027

Last Updated

December 12, 2024

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will not share

autosomal dominant AD where mutation status is known for participants

Locations

SE(1)