Alzheimer's Disease (AD)AmyClearADNCT05059158
Amyloid-β Clearance Mechanisms in Alzheimer's Disease
An observational study of Alzheimer's Disease (AD), run by Ludwig-Maximilians - University of Munich at 1 site in Germany.
Trial summary
The focus of this study is to examine the protein-plaque clearance (Aß) in relation to the blood-brain-barrier, the glymphatic system, brain lymphatic system and enzymatic degradation. Read more about this study
- Who is it for?
- Ages 50 to 85 years
- Conditions the study is for
- Alzheimer's Disease (AD)
- What is being tested?
- positron emission tomography (PET)
- Type of treatment
- Surgery or procedure
- How many people
- 60 participants
- Where
- 1 siteGermany
- Study dates
- 1 Jun 2021to Oct 2025
- Phase
- Observational
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: SCD, MCI or AD
Who may be able to join
- Diagnosis of amnestic MCI or AD dementia or clinical normal
- Able to provide written informed consent
- Unchanged pharmacotherapy within 4 days prior to the study specific assessments
- Fluent in German
Who cannot join
- Unable to give informed consent or has a legal guardian
- Other severe mental disorder, e.g. schizophrenia or bipolar affective disorder
- Clinically relevant depression
- Acute suicidality
- Current alcohol, drug or medication abuse
- History of severe traumatic brain injury within 3 months prior to inclusion
Show all 15Show fewer
- Structural lesions of the basal ganglia or brain stem
- Severe neurological disorder including (but not limited to) epilepsy, systemic disorders, stroke, repeated transient ischaemic attacks, increased brain intracranial pressure, normal pressure hydrocephalus
- Severe medical disorders including (but not limited to) heart failure, respiratory failure, uncontrolled severe arterial hypertension
- Electronic implants (e.g. cardiac pacemaker) or other MRI contraindication
- Renal failure > stage 3 (GFR < 30 mL/min)
- Pregnancy
- Unresolved malignancies within two years prior to inclusion
- Severe current infections or other chronic or systemic disorders
- Other circumstances which preclude participation based on the investigator's judgement
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
Klinik und Poliklinik für Psychiatrie und Psychotherapie des LMU Klinikums
München, Bavaria, 80336
Robert Perneczky, Prof. Dr., +49 89 4400 55863, PSY.Alzheimerzentrum@med.uni-muenchen.de
Lena Burow, M.Sc., +49 89 4400 55898, lena.burow@med.uni-muenchen.de
About this study
Official title: Amyloid-β Clearance Mechanisms: A Multi-modal Study on Lymphatic, Glymphatic and Blood-brain-barrier Function in Alzheimer's Disease
The focus of this study is to examine the protein-plaque clearance (Aß) in relation to the blood-brain-barrier, the glymphatic system, brain lymphatic system and enzymatic degradation. In order to achieve this aim the investigators intend to study participants with a Subjective Cognitive Decline, Mild Cognitive Impairment and a mild Alzheimer's disease.
Read the detailed description
In this study, the investigators want to examine the different mechanisms of the accumulation and the clearance of Aß- deposits with imaging methods. One focus of the study is an improved characterisation of a blood-brain-barrier disorder (which seems to have an impact on the Aß-accumulation). Another main aim is to provide an improved mechanistic clearance model, which integrates crucial components such as the recently proposed cerebral glymphatic and lymphatic pathways, and which addresses the interaction between the different components and their individual contribution to Aβ removal from the brain. A possible connection between sleep and an altered transport mechanism will be analysed. The prospective study cohort (N ~60) will include patients with Mild Cognitive Impairment, mild clinical AD and Subjective Cognitive Decline. All study participants will undergo a detailed clinical and neuropsychological assessment according to a standardised protocol (i.a. MRI, PET, CSF, actigraphy). Follow-up assessments will not be performed in the present project, but are planned in a subsequent study, pending further funding.
- Conditions
- Alzheimer's Disease (AD)
- Being tested
- positron emission tomography (PET)
- Keywords
- Alzheimer's Disease, Mild Cognitive Impairment, Sleep, Actigraphy, Blood-brain-barrier, Amyloid-β Clearance Mechanisms
- Medical subject headings
- Alzheimer Disease, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
positron emission tomography (PET)Radiation
18-Flutemetamol PET (clinical indicated) is going to be performed at the visit.
| Study group | Role | What they receive |
|---|---|---|
| Alzheimer's Disease | Patients with a Alzheimer's Disease diagnosis Receives: Radiation: positron emission tomography (PET) | |
| Mild Cognitive Impairment | Patients with a mild cognitive impairment diagnosis Receives: Radiation: positron emission tomography (PET) | |
| Subjective Cognitive Decline | Patients with a subjective cognitive decline diagnosis Receives: Radiation: positron emission tomography (PET) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Differences in the disruption of the brain-blood-barrier between the subgroups
Name of Measurement: Ktrans; Measurement Tool: DCI sequence (MRI); Unit: min -1
Measured: Baseline
Clearance mechanisms and glymphatic or cerebral lymphatic system
Can a disruption in the cerebral clearance through the glymphatic or cerebral lymphatic system be proven in patients with AD, MCI or SCD?
Name of Measurement: DTI ALPS; Measurement Tool: DTI MRI; Unit: mean (Dxpro, Dypro)/ mean (Dypro, Dzasc)
Measured: Baseline
Connection between the structural/functional connectivity of the resting networks and the clearance mechanisms
Correlations between correlations of bold fluctuations/ number of tracts and DTI ALPS Index
Measured: Baseline
Differences between sleep and activity in SCD, MCI and AD; Do they have a mediator role in association of the BBB disruption and Aß pathology?
Name of Measurement: Sleep Efficiency, Sleep Time, PIM, TAT, ZCM ;Measurement Tool: Actigraphy; Units: minutes, count
Measured: Baseline
Connection between clinical symptoms, Aß pathology and BBB disorder
Correlations between Clinical Dementia Rating Sum of Boxes, CSF markers (pg/ml) and Aß PET, SUVr and Ktrans map
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2021
- Study start1 Jun 2021
- Primary completionSep 2025 (estimated)
- Study completionOct 2025 (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 Alzheimer's Disease (AD)Studies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ludwig-Maximilians - University of Munich
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Robert Perneczky, Ludwig-Maximilians - University of Munich
- Investigators
- Robert Perneczky, Prof.Dr.med., Principal investigator, Klinik und Poliklinik für Psychiatrie und Psychotherapie des LMU Klinikums
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05059158
- Sponsor's protocol ID
- 18-606
- Other IDs
- 18-606, 1081
- Acronym
- AmyClearAD
- Status last verified
- Jul 2025
- First submitted
- 15 Jul 2021
- Last updated
- 4 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Kurz C, Hattenkofer D, Pihale-Haug M, Hufnagel A, Gursel SU, Brendel M, Rauchmann BS, Levin J, Hoglinger G, Perneczky R. Head-to-head comparison of neurodegeneration biomarkers across two analytical platforms in Alzheimer's disease. Aging Clin Exp Res. 2026 Jun 25;38(1):157. doi: 10.1007/s40520-026-03420-5.
PubMed 42348024
Study at a glance
From the registry record, last updated by the sponsor on 4 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Amyloid-β Clearance Mechanisms: A Multi-modal Study on Lymphatic, Glymphatic and Blood-brain-barrier Function in Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT05059158
- Acronym / sponsor ID
- AmyClearAD / 18-606
- Conditions
- Alzheimer's Disease (AD)
- Keywords
- Alzheimer's Disease, Mild Cognitive Impairment, Sleep, Actigraphy, Blood-brain-barrier, Amyloid-β Clearance Mechanisms
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Ludwig-Maximilians - University of MunichUniversity, hospital or other
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- Sep 2025 (estimated)
- Study completion
- Oct 2025 (estimated)
- First posted
- 28 Sep 2021 (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.
The focus of this study is to examine the protein-plaque clearance (Aß) in relation to the blood-brain-barrier, the glymphatic system, brain lymphatic system and enzymatic degradation. In order to achieve this aim the investigators intend to study participants with a Subjective Cognitive Decline, Mild Cognitive Impairment and a mild Alzheimer's disease.
Detailed description
In this study, the investigators want to examine the different mechanisms of the accumulation and the clearance of Aß- deposits with imaging methods. One focus of the study is an improved characterisation of a blood-brain-barrier disorder (which seems to have an impact on the Aß-accumulation). Another main aim is to provide an improved mechanistic clearance model, which integrates crucial components such as the recently proposed cerebral glymphatic and lymphatic pathways, and which addresses the interaction between the different components and their individual contribution to Aβ removal from the brain. A possible connection between sleep and an altered transport mechanism will be analysed. The prospective study cohort (N ~60) will include patients with Mild Cognitive Impairment, mild clinical AD and Subjective Cognitive Decline. All study participants will undergo a detailed clinical and neuropsychological assessment according to a standardised protocol (i.a. MRI, PET, CSF, actigraphy). Follow-up assessments will not be performed in the present project, but are planned in a subsequent study, pending further funding.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Alzheimer's Disease | – | Radiation: positron emission tomography (PET)Patients with a Alzheimer's Disease diagnosis |
| Mild Cognitive Impairment | – | Radiation: positron emission tomography (PET)Patients with a mild cognitive impairment diagnosis |
| Subjective Cognitive Decline | – | Radiation: positron emission tomography (PET)Patients with a subjective cognitive decline diagnosis |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- SCD, MCI or AD
Key inclusion criteria (4 listed)
- Diagnosis of amnestic MCI or AD dementia or clinical normal
- Able to provide written informed consent
- Unchanged pharmacotherapy within 4 days prior to the study specific assessments
- Fluent in German
Key exclusion criteria (15 listed)
- Unable to give informed consent or has a legal guardian
- Other severe mental disorder, e.g. schizophrenia or bipolar affective disorder
- Clinically relevant depression
- Acute suicidality
- Current alcohol, drug or medication abuse
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 |
|---|---|---|
| positron emission tomography (PET)18-Flutemetamol PET (clinical indicated) is going to be performed at the visit. | Radiation | Alzheimer's Disease, Mild Cognitive Impairment, Subjective Cognitive Decline |
Primary outcome
Differences in the disruption of the brain-blood-barrier between the subgroups
Time frame: Baseline
Name of Measurement: Ktrans; Measurement Tool: DCI sequence (MRI); Unit: min -1
Clearance mechanisms and glymphatic or cerebral lymphatic system
Time frame: Baseline
Can a disruption in the cerebral clearance through the glymphatic or cerebral lymphatic system be proven in patients with AD, MCI or SCD? Name of Measurement: DTI ALPS; Measurement Tool: DTI MRI; Unit: mean (Dxpro, Dypro)/ mean (Dypro, Dzasc)
Connection between the structural/functional connectivity of the resting networks and the clearance mechanisms
Time frame: Baseline
Correlations between correlations of bold fluctuations/ number of tracts and DTI ALPS Index
Differences between sleep and activity in SCD, MCI and AD; Do they have a mediator role in association of the BBB disruption and Aß pathology?
Time frame: Baseline
Name of Measurement: Sleep Efficiency, Sleep Time, PIM, TAT, ZCM ;Measurement Tool: Actigraphy; Units: minutes, count
Connection between clinical symptoms, Aß pathology and BBB disorder
Time frame: Baseline
Correlations between Clinical Dementia Rating Sum of Boxes, CSF markers (pg/ml) and Aß PET, SUVr and Ktrans map
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 4 Jul 2025.
- Derived from this study: PubMed 42348024Kurz C, Hattenkofer D, Pihale-Haug M, Hufnagel A, Gursel SU, Brendel M, Rauchmann BS, Levin J, Hoglinger G, Perneczky R. Head-to-head comparison of neurodegeneration biomarkers across two analytical platforms in Alzheimer's disease. Aging Clin Exp Res. 2026 Jun 25;38(1):157. doi: 10.1007/s40520-026-03420-5.
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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.
Robert Perneczky, Prof.Dr.med. principal investigator
Klinik und Poliklinik für Psychiatrie und Psychotherapie des LMU Klinikums
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Alzheimer's Disease (AD), run by Ludwig-Maximilians - University of Munich at 1 site in Germany.
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 4 inclusion and 15 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: looking for participants now, as of the sponsor's last update on 4 Jul 2025. 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 Germany. 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?
Contact Robert Perneczky, Prof.Dr.med. (+4989440055863, PSY.Alzheimerzentrum@med.uni-muenchen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Differences in the disruption of the brain-blood-barrier between the subgroups (time frame: Baseline). The study lists 5 primary outcomes in all. 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 NCT05059158, 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 4 Jul 2025.