Alzheimer´s DiseaseROADADNCT06731842
Molecular PET Imaging and Plasma Biomarkers in Alzheimer´s Disease and Other Neurodegenerative Diseases
A study testing 18F-RO948 in people with Alzheimer´s Disease, run by Karolinska Institutet at 1 site in Sweden.
Trial 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… Read more about this study
- Who is it for?
- Ages 30 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Alzheimer´s Disease
- What is being tested?
- 18F-RO948
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteSweden
- Study dates
- 15 May 2022to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- cancer and other serious disease
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read the detailed description
Multi-PET /MRI studies , fluid biomarkers (CSF, plasma) analysis, neuropsychological testing is performed in subjects carriers and non-carriers of different APP, PS autosomal dominant AD mutatation. Both presymptomatic and symptomatic carriers and non-carriers are recruited (age range -30 to +15 years from first clinical symptoms). For comparison also a group of healthy eldersly as well as patients undergoing memory assessment with diagnosis of mild cognitive impairment (amyloid negative /amyloid positive) and diagnosis sporadic Alzheimer´s diases are recruited from Karolinska memory clinic and undergoing similar Multi-PET/MRI studies , fluid biomarker analysis, neuropsycholigal testing. The aim is to describe the evolution and spreading of tau in brain in Alzheimer continuum and compare with other pathological markers with aim of develop new diagnostic markers and therapeutic targets.
- Conditions
- Alzheimer´s Disease
- Being tested
- 18F-RO948
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
18F-RO948Other
Tau PET imaging using the tau PET tracer 18F-RO948 in famial and sporadic Alzheimer´s disease
| Study group | Role | What they receive |
|---|---|---|
| TAU PET and MRI investigation | Other | Not described Receives: Other: 18F-RO948 |
What is being measured
The primary outcome is the main question the study is designed to answer.
PET measurement of regional tau spreading in brain during Alzheimer continuum
Anaysis of regional deposition of tau in brain
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2024
- Study start15 May 2022
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer´s DiseaseStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Agneta Nordberg, Karolinska Institutet
- Investigators
- Agneta K NORDBERG, MD PhD, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06731842
- Sponsor's protocol ID
- 2023-02649
- Other IDs
- 2023
- Acronym
- ROADAD
- Status last verified
- Sep 2024
- First submitted
- 9 Dec 2024
- Last updated
- 12 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: autosomal dominant AD where mutation status is known for participants
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Molecular PET Imaging and Plasma Biomarkers in Alzheimer´s Disease and Other Neurodegenerative Diseases
- ClinicalTrials.gov ID
- NCT06731842
- Acronym / sponsor ID
- ROADAD / 2023-02649
- Conditions
- Alzheimer´s Disease
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- 15 May 2022 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 12 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Multi-PET /MRI studies , fluid biomarkers (CSF, plasma) analysis, neuropsychological testing is performed in subjects carriers and non-carriers of different APP, PS autosomal dominant AD mutatation. Both presymptomatic and symptomatic carriers and non-carriers are recruited (age range -30 to +15 years from first clinical symptoms). For comparison also a group of healthy eldersly as well as patients undergoing memory assessment with diagnosis of mild cognitive impairment (amyloid negative /amyloid positive) and diagnosis sporadic Alzheimer´s diases are recruited from Karolinska memory clinic and undergoing similar Multi-PET/MRI studies , fluid biomarker analysis, neuropsycholigal testing. The aim is to describe the evolution and spreading of tau in brain in Alzheimer continuum and compare with other pathological markers with aim of develop new diagnostic markers and therapeutic targets.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TAU PET and MRI investigation | Other | Other: 18F-RO948 |
Who may qualify
- Ages
- 30 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- cancer and other serious disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 18F-RO948Tau PET imaging using the tau PET tracer 18F-RO948 in famial and sporadic Alzheimer´s disease | Other | TAU PET and MRI investigation |
Primary outcome
PET measurement of regional tau spreading in brain during Alzheimer continuum
Time frame: 3 years
Anaysis of regional deposition of tau in brain
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2024.
- Individual participant dataSharing planned: No. autosomal dominant AD where mutation status is known for participants
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Agneta K NORDBERG, MD PhD principal investigator
Karolinska Institutet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 18F-RO948 in people with Alzheimer´s Disease, run by Karolinska Institutet at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 12 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PET measurement of regional tau spreading in brain during Alzheimer continuum (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2024.