NCT02958670Active, not recruiting
Imaging Tau Deposition in the Brain of Elderly Subjects
Source: ClinicalTrials.gov · Last updated 9 Nov 2023
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 141 (actual)
- First submitted
- 1 Nov 2016
- Start date
- Nov 2016
- Primary completion date
- Dec 2024
- Lead sponsor
- University of Zurich
- Diseases
- Alzheimer disease
- NCT number
- NCT02958670
What you commit to
- Study type: Interventional
- Participants enrolled: 141
- From Nov 2016 to the primary completion date, Dec 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous or current participation in anti-beta-amyloid or anti-tau therapeutic trials
Other illness
- Evidence for cognitive impairment mainly attributed to a non-neurodegenerative underlying medical condition (e.g. medication, brain tumor, severe heart insufficiency, hepatic encephalopathy)
- Disease or other condition with a potential to interfere with study participation
- Ongoing infection with human immunodeficiency virus (HIV) or any hepatitis virus
- Severe illness likely to cause disability that interferes with study procedures in the following years
- 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
- Other condition that might pose a risk to the study subject in the opinion of the investigator
Other
- Evidence of larger cerebral infarcts, or lacunes in critical memory structures
- Active, acute or chronic leukemia
- MR exclusion criteria
- PET exclusion criteria
- Contraindications against venous puncture
- Exclusion criteria for subproject CSF sampling
Who the study is looking for
- 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
- 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
Age in the registry: 50 years to - · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Institute for Regenerative Medicine (IREM) Coordinator of this site? Confirm its status | Schlieren | Switzerland | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.