Studies how brain cells that regulate hormones relate to dementia
Observes brain-region cells and blood samples in people with Alzheimer's or frontotemporal dementia.
Key facts
- Who runs it
- University Hospital, Lille
- Where
- Lille, FranceSee the site
- Trial code
- Registry title
- Tanycytes in Alzheimer's Disease and Frontotemporal Dementia
- Status
- Recruiting
- People taking part
- 102 people, planned
- Started
- 6 Sept 2022
- Planned end
- Oct 2026
- Type of study
- Observational, 3 groups
- Treatments tested
- Lumbar puncture
- blood sample
- Record updated
- 18 May 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults aged 40 to 85 who can have a lumbar puncture. Three groups: people with Alzheimer's disease, people with frontotemporal dementia, and people without memory problems.
- Age
- 40 to 85 years
- Sex
- All sexes can join.
- Disease stage
- Alzheimer's disease: probable Alzheimer's disease dementia with MMSE of 16 or more. Frontotemporal dementia: probable frontotemporal dementia with MMSE of 16 or more. Controls: no memory complaint and a normal MMSE.
- Earlier treatment
- People taking metformin cannot join.
Main reasons for not taking part
- Cannot have a lumbar puncture or an MRI scan
- Other brain diseases, such as Lewy body dementia, Parkinson's disease, brain tumor, stroke or epilepsy
- Severe metabolic or hormone disorder
- Known active HCV, HBV or HIV
- Pregnancy or breastfeeding; weight under 45 kg (99 lb)
The registry criteria, word for word
Show all 27 criteriaShow less
Who can take part
- Subjects able to undergo a lumbar puncture
- Subjects registered with the French Social Security, in agreement with the French law on biomedical experimentation; To be assigned in the study subgroups, subjects will have to fulfill the specific following criteria:; Group 1: Controls
- absence of cognitive complaint (completion of the memory complaint questionnaire)
- absence of significant cognitive impairment: normal MMSE according to age and education levels
- Subjects capable of and willing to comply with the protocol and to give their written informed consents after having received and understood the subject information Group 2: Alzheimer's Disease
- Diagnosis of probable Alzheimer's disease dementia according to the NIA 2011 criteria1
- MMSE ≥ 16
- Subjects who have a study partner. The study partner is required to complete several scales and to drive back the subject after the lumbar puncture for safety reasons. If the subjects or their study partners are not able to drive, their transport fees will be reimbursed by the promotor
- Subjects and study partners capable of and willing to comply with the protocol and to give their written informed consents after having received and understood the subject information. According to the legal protection or the mental capacities of the subject, the subject will be accompanied by a legally acceptable representative during this procedure Group 3: Frontotemporal Dementia
- Diagnosis of probable frontotemporal dementia according to the FTDC 2011 criteria2
- MMSE ≥ 16
- Subjects who have a study partner. The study partner is required to complete several scales and to drive back the subject after the lumbar puncture for safety reasons. If the subjects or their study partners are not able to drive, their transport fees will be reimbursed by the promotor
- Subjects and study partners capable of and willing to comply with the protocol and to give their written informed consents after having received and understood the subject information. According to the legal protection or the mental capacities of the subject, the subject be accompanied by a legally acceptable representative during this procedure
Who cannot take part
- Subjects with severe metabolic or endocrine disorder (excluding hypothyroidism under stable hormone replacement therapy, controlled type 2 diabetes or common dyslipidaemia), previously known or identified at screening
- Subjects with excessive alcohol intake or drug abuse, in the judgment of the investigator
- Subjects with dementia caused by a non-neurodegenerative disease, including patients with severe cerebrovascular risk factor load
- Weighted less than 45 kg; Associated illnesses or conditions:
- Subjects with other neurodegenerative disease such as Lewy body dementia and Parkinson's disease
- Subjects with other serious neurological disorder such as brain tumor, stroke, epilepsy, hydrocephalus and any condition which contraindicates, in the investigator's judgment, entry to the study
- Subjects with known active HCV, HBV or HIV
- Subjects with clinical or significant laboratory abnormalities, previously known or identified at screening, in the judgment of the investigator; Others:
- Pregnancy or breastfeeding or Women of childbearing age without effective contraception (a pregnancy test will be done)
- General exclusion criteria:
- Subjects who have contraindications to perform a lumbar puncture
- Subjects who have contraindications to perform a MRI scan
- Subjects under metformin treatment; Biological exclusion criteria:
- Subjects who, in the opinion of the investigator, have a risk of non-compliance to the study procedures or who are otherwise not appropriate to include in this clinical trial (for example, being impossible to contact in case of emergency)
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 40 and 85 years old?
Where in France
- Memory Resources and Research Center LilleLille, FranceContact: Thibaud LEBOUVIER, MD, PhDTaking people
About the trial
What the trial wants to find out
Metabolic and hormonal deregulations are both a risk factor and a hallmark of Alzheimer's disease (AD) and frontotemporal dementia (FTD), occurring early in the course of the disease. In FTD in particular, hyperorality and dietary changes are associated with metabolic and hormonal changes such as altered levels of the anorexigenic hormone leptin.
Read full original descriptionShow less
The hypothalamus is a brain region that controls metabolism and hormonal systems. Hypothalamic function depends on its ability to sense peripheral signals. The hypothalamus sits on a circumventricular organ called the median eminence (ME) that puts it in contact with systemic blood circulation. In the ME, fenestrated capillaries allow the diffusion of bloodborne factors. However, despite the lack of blood-brain barrier at brain microvessels, diffusion is controlled by specialized ependymoglial cells, the tanycytes, which exert a barrier function between the ME and the third ventricle and controls the access of blood-borne molecules into the hypothalamus. Previous work from our laboratory and the ERC consortium has highlighted the role of tanycytes not only in the regulation of the release of neurohormones from neuroendocrine nerve terminals into the pituitary portal blood circulation, but also in the transport of circulating leptin into the hypothalamus. Hence hypothalamic dysfunction in AD and FTD can result either from dysregulation of neuroendocrine secretions, direct neuronal loss or from defective transport (and hence resistance) to hormones like leptin.
This study is to demonstrate that leptin transport though tanycytes is early altered in FTD and AD and correlates
The 3 groups in the trial
- Group 1: Controls
Treatment: Lumbar puncture and blood sample
- Group 2: Alzheimer's Disease
Treatment: Lumbar puncture and blood sample
- Group 3: Frontotemporal Dementia
Treatment: Lumbar puncture and blood sample
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- TANYCYTES' ROLE IN ALZHEIMER'S DISEASE AND FRONTOTEMPORAL DEMENTIA: ARE THEY THE KEY TO WELL AGING?
- Plain-language title
- Studies how brain cells that regulate hormones relate to dementiaGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Fit questions
- Built from NCT05288842, who can take part
- Record updated
- 18 May 2026