Mild Cognitive ImpairmentAdd-TauNCT02958670
Imaging Tau Deposition in the Brain of Elderly Subjects
A study testing 18F-AV-1451 (Tau-PET tracer) in people with Mild Cognitive Impairment and Healthy, run by University of Zurich at 1 site in Switzerland.
Trial summary
Cerebral accumulation of tau and beta-amyloid are major factors of Alzheimer's disease pathology. A novel Positron Emission Tomography (PET) tracer (18-F-AV-1451) now offers the ability to study tau protein deposition in vivo in subjects, in which information on cerebral amyloid deposition has already been gathered. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Mild Cognitive Impairment, Healthy, Alzheimer Disease
- What is being tested?
- 18F-AV-1451 (Tau-PET tracer)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 141 participants
- Where
- 1 siteSwitzerland
- Study dates
- Nov 2016to Dec 2029
- 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 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subject belongs to one of the following groups:
- No cognitive impairment
- Mild cognitive impairment according to Winblad et al., 2004
- Clinical diagnosis of dementia due to Alzheimer's disease compatible with DSM IV criteria or revised NINCDS-ADRDA criteria
- Evidence of neurodegenerative disease other than AD
- Written informed consent approved by the regulatory authorities
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- Age ≥ 50 years, women must be without childbearing potential
- Pre-existing PET information (11C-Pittsburgh Compound B, 18F-Flutemetamol) on cerebral amyloid deposition
- German speaking or sufficient knowledge of German language to perform study assessments
- Subject is willing and able to name an informant who can give adequate information on the scales where informant input is required
Who cannot join
- Evidence for cognitive impairment mainly attributed to a non-neurodegenerative underlying medical condition (e.g. medication, brain tumor, severe heart insufficiency, hepatic encephalopathy)
- Evidence of larger cerebral infarcts, or lacunes in critical memory structures
- Disease or other condition with a potential to interfere with study participation
- Ongoing infection with human immunodeficiency virus (HIV) or any hepatitis virus
- Active, acute or chronic leukemia
- Severe illness likely to cause disability that interferes with study procedures in the following years
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- Evidence of acute psychiatric disease (upon clinical decision) which may be a cause of cognitive impairment. Patients with a history of major depression under stable medication may be included. Patients with low dose intake of benzodiazepines may also be included upon clinician's decision
- Previous or current participation in anti-beta-amyloid or anti-tau therapeutic trials
- MR exclusion criteria
- PET exclusion criteria
- Contraindications against venous puncture
- Other condition that might pose a risk to the study subject in the opinion of the investigator
- Exclusion criteria for subproject CSF sampling
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Institute for Regenerative Medicine (IREM)
Schlieren, Canton of Zurich, 8952
About this study
Cerebral accumulation of tau and beta-amyloid are major factors of Alzheimer's disease pathology. A novel Positron Emission Tomography (PET) tracer (18-F-AV-1451) now offers the ability to study tau protein deposition in vivo in subjects, in which information on cerebral amyloid deposition has already been gathered. This enables to study effects of tau deposition on neuronal integrity, their relation to effects of beta-amyloid deposition and how this contributes to cognitive impairment or well-being in the elderly.
Read the detailed description
This is a single-center exploratory observational clinical study combining cross sectional and longitudinal aspects. It contains 18F-AV-1451-PET as an intervention. The primary objective is to measure tau deposition with 18-F-AV1451-PET based on voxel wise or volume based quantitative assessments and to study the effects of Tau deposition on the organism by identification of factors correlating to the measured tau deposition. Study participants will be followed for up to 8 years.
To date cerebral tau pathology in vivo was only estimated by cerebrospinal fluid (CSF) tau or CSF phospho-tau which precludes a study of topical distribution and interplay with Abeta pathology. 18F-AV-1451 offers the chance to visualize tau pathology and to study effects of tau on brain structure, brain physiology and cognitive function. Ideally, these effects are studied in well characterized individuals in whom other important pathological factors are already known.
We therefore plan to study tau pathology measured by 18F-AV-1451 in subjects with already existing data on cerebral amyloid deposition (11C-Pittsburgh Compound C, Flutemetamol). We will be able to relate tau pathology to past and prospective cognitive performance assessed by a detailed neuro¬psychological examination, and we will be able to investigate whether cerebral tau pathology is reflected by peripheral blood biomarkers. For this purpose we will include elderly subjects with various degrees of cognitive performance (cognitively healthy, mild cognitive impairment, dementia) and various degrees of cerebral amyloid deposition (dichotomized or quantitative). We will also include Frontotemporal Lobar Degeneration (FTLD) cases to study tau effects in neurodegenerative disease in the absence of beta-amyloid.
Our hypotheses are the following:
- We assume that it is possible to identify tau deposition in subjects with and without cerebral Abeta deposition.
- We hypothesize that tau-deposition will be associated with structural and physiological brain changes and that there are synergistic effects of the amount of tau and Abeta pathology on certain brain regions and on cognitive function.
- Being tested
- 18F-AV-1451 (Tau-PET tracer)
- Medical subject headings
- Cognitive Dysfunction, Alzheimer Disease, Neurocognitive Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
18F-AV-1451 (Tau-PET tracer)Other
Single i.v. administration of 18F-AV-1451 (Tau-PET tracer) and consecutive Positron-Emission-Tomography-Scan
| Study group | Role | What they receive |
|---|---|---|
| 18F-AV-1451-PET | Experimental | All subjects receive a Scan for assessment of TAU with the radiotracer 18-F-AV-1451 Receives: Other: 18F-AV-1451 (Tau-PET tracer) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Volume of Interest (VOI) or Voxel based assessment of 18F-AV-1451-PET-signal
Measured: Baseline measurement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2016 (estimated)
- Study startNov 2016
- Primary completionDec 2024 (estimated)
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mild Cognitive ImpairmentStudies of the same condition, open and under way.
- More trials run by University of ZurichThe 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 141 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Collaborators
- Avid Radiopharmaceuticals, Swiss Federal Institute of Technology
- Responsible party
- Sponsor
- Investigators
- Christoph Hock, Prof.Dr. med, Principal investigator, Professor for Biological Psychiatry, Institute for Regenerative Medicine, University of Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02958670
- Sponsor's protocol ID
- KEK-ZH_Nr_2016-01079_V10.0
- Acronym
- Add-Tau
- Status last verified
- Nov 2023
- First submitted
- 1 Nov 2016
- Last updated
- 9 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Bachmann D, Saake A, Studer S, Buchmann A, Rauen K, Gruber E, Michels L, Nitsch RM, Hock C, Gietl A, Treyer V; Alzheimer's Disease Neuroimaging Initiative. Hypertension and cerebral blood flow in the development of Alzheimer's disease. Alzheimers Dement. 2024 Nov;20(11):7729-7744. doi: 10.1002/alz.14233. Epub 2024 Sep 10.
PubMed 39254220
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Imaging Tau Deposition in the Brain of Elderly Subjects
- ClinicalTrials.gov ID
- NCT02958670
- Acronym / sponsor ID
- Add-Tau / KEK-ZH_Nr_2016-01079_V10.0
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 141 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Collaborators
- Avid Radiopharmaceuticals, Swiss Federal Institute of Technology
- Study start
- Nov 2016 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 8 Nov 2016 (estimated)
- 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.
Cerebral accumulation of tau and beta-amyloid are major factors of Alzheimer's disease pathology. A novel Positron Emission Tomography (PET) tracer (18-F-AV-1451) now offers the ability to study tau protein deposition in vivo in subjects, in which information on cerebral amyloid deposition has already been gathered. This enables to study effects of tau deposition on neuronal integrity, their relation to effects of beta-amyloid deposition and how this contributes to cognitive impairment or well-being in the elderly.
Detailed description
This is a single-center exploratory observational clinical study combining cross sectional and longitudinal aspects. It contains 18F-AV-1451-PET as an intervention. The primary objective is to measure tau deposition with 18-F-AV1451-PET based on voxel wise or volume based quantitative assessments and to study the effects of Tau deposition on the organism by identification of factors correlating to the measured tau deposition. Study participants will be followed for up to 8 years.
To date cerebral tau pathology in vivo was only estimated by cerebrospinal fluid (CSF) tau or CSF phospho-tau which precludes a study of topical distribution and interplay with Abeta pathology. 18F-AV-1451 offers the chance to visualize tau pathology and to study effects of tau on brain structure, brain physiology and cognitive function. Ideally, these effects are studied in well characterized individuals in whom other important pathological factors are already known.
We therefore plan to study tau pathology measured by 18F-AV-1451 in subjects with already existing data on cerebral amyloid deposition (11C-Pittsburgh Compound C, Flutemetamol). We will be able to relate tau pathology to past and prospective cognitive performance assessed by a detailed neuro¬psychological examination, and we will be able to investigate whether cerebral tau pathology is reflected by peripheral blood biomarkers. For this purpose we will include elderly subjects with various degrees of cognitive performance (cognitively healthy, mild cognitive impairment, dementia) and various degrees of cerebral amyloid deposition (dichotomized or quantitative). We will also include Frontotemporal Lobar Degeneration (FTLD) cases to study tau effects in neurodegenerative disease in the absence of beta-amyloid.
Our hypotheses are the following:
- We assume that it is possible to identify tau deposition in subjects with and without cerebral Abeta deposition.
- We hypothesize that tau-deposition will be associated with structural and physiological brain changes and that there are synergistic effects of the amount of tau and Abeta pathology on certain brain regions and on cognitive function.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 18F-AV-1451-PET | Experimental | Other: 18F-AV-1451 (Tau-PET tracer)All subjects receive a Scan for assessment of TAU with the radiotracer 18-F-AV-1451 |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Subject belongs to one of the following groups:
- Written informed consent approved by the regulatory authorities
- Age ≥ 50 years, women must be without childbearing potential
- Pre-existing PET information (11C-Pittsburgh Compound B, 18F-Flutemetamol) on cerebral amyloid deposition
- German speaking or sufficient knowledge of German language to perform study assessments
Key exclusion criteria (13 listed)
- Evidence for cognitive impairment mainly attributed to a non-neurodegenerative underlying medical condition (e.g. medication, brain tumor, severe heart insufficiency, hepatic encephalopathy)
- Evidence of larger cerebral infarcts, or lacunes in critical memory structures
- Disease or other condition with a potential to interfere with study participation
- Ongoing infection with human immunodeficiency virus (HIV) or any hepatitis virus
- Active, acute or chronic leukemia
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-AV-1451 (Tau-PET tracer)Single i.v. administration of 18F-AV-1451 (Tau-PET tracer) and consecutive Positron-Emission-Tomography-Scan | Other | 18F-AV-1451-PET |
Primary outcome
Volume of Interest (VOI) or Voxel based assessment of 18F-AV-1451-PET-signal
Time frame: Baseline measurement
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 9 Nov 2023.
- Derived from this study: PubMed 39254220Bachmann D, Saake A, Studer S, Buchmann A, Rauen K, Gruber E, Michels L, Nitsch RM, Hock C, Gietl A, Treyer V; Alzheimer's Disease Neuroimaging Initiative. Hypertension and cerebral blood flow in the development of Alzheimer's disease. Alzheimers Dement. 2024 Nov;20(11):7729-7744. doi: 10.1002/alz.14233. Epub 2024 Sep 10.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Christoph Hock, Prof.Dr. med principal investigator
Professor for Biological Psychiatry, Institute for Regenerative Medicine, University of Zurich
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-AV-1451 (Tau-PET tracer) in people with Mild Cognitive Impairment and Healthy, run by University of Zurich at 1 site in Switzerland.
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 10 inclusion and 13 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: under way, not looking for participants, as of the sponsor's last update on 9 Nov 2023. 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 Switzerland. 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?
Volume of Interest (VOI) or Voxel based assessment of 18F-AV-1451-PET-signal (time frame: Baseline measurement). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02958670, which also lists 1 linked publication.
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 9 Nov 2023.