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New treatment option for Alzheimer Disease, Early Onset
Official title MECHANISMS OF NEURONAL RESILIENCE IN ALZHEIMER'S DISEASE AND ITS FOCAL VARIANTS: A PET/MR STUDY
ClinicalTrials.gov ID: NCT04150198
What this study is testing
- What it's testing
- Patients with Alzheimer's disease and with early onset of symptoms (\<65 years) (AD-Y) have a multi-domain cognitive deficit, whereas memory disorders (typical of the elderly patient's AD) are less often in the foreground. In addition, some MA-J have an atypical phenotype indicating focal brain damage, although they have the same pathological lesions: amyloid deposits and tau protein deposition (DNF).
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 40 to 80. Healthy volunteers may be eligible.
You may be able to join if
- For all people:
- Affiliation to a social security insurance or beneficiary
- Informed consent form signed by the participant or his / her legal representative
- Participants aged 40 to 80 years.
- Selection of AD-Y group \- In vivo proof of Alzheimer's pathology:
See the full eligibility criteria
- For all people:
- Affiliation to a social security insurance or beneficiary
- Informed consent form signed by the participant or his / her legal representative
- Participants aged 40 to 80 years.
- Selection of AD-Y group \- In vivo proof of Alzheimer's pathology:
- Determination of specific proteins on the cerebrospinal fluid (CSF, a routine care procedure). The values considered pathological (AD) are Aβ1-42 peptide \ 450 and phosphorylated tau protein\> 60, IATI index \ 1.23 as...
- And / or a positive PET-amyloid imaging test.
- Early-onset episodic memory deficit (\<65 years), progressive onset with evidence of hippocampal amnesic syndrome at neuropsychological assessment. In memory tests, the amnesic hippocampal syndrome is defined by: a...
- PCA group selection Patients with a clinical and cognitive profile suggestive of PCA, characterized by:
- an in vivo proof of the Alzheimer pathology (see selection of the AD-Y group)
- a specific impairment of neuro-visual abilities, in the absence of major disorders of episodic memory (hippocampal) and executive functions. Two possible variants:
- occipito-temporal variant: visuo-perceptive deficit in the foreground, early onset and progressive worsening; lack of visual identification of objects, symbols, words or faces;
- biparietal variant: visuospatial deficit in the foreground, early settlement and progressive worsening; Gerstmann syndrome; Balint syndrome; gestural apraxia; visual-spatial neglect.
- Selection of the control people group
- Normal neurological and neuropsychological examinations.
- Control people will be matched in age to patients. Non-
- General non-
- Medical history of torsade de pointe or risk of torsade de pointes
- Patient treated with drugs known to lengthen QT (see www.crediblemeds.org)
- Contraindication to radiopharmaceutical injection: For precautions of safety of use of the radiopharmaceutical, a blood sample allowing to check the renal and hepatic functions will be realized before imagery. The delay...
- Patient deprived of liberty by decision of justice or not benefiting from social cover.
- Person in the process of participating in another therapeutic research or in a period of exclusion from another research.
- Participants with a contraindication to MRI: pacemaker or cardiac defibrillator, implanted equipment activated by an electrical, magnetic or mechanical system, haemostatic clips of intracerebral aneurysms or carotid...
- Contraindication to radiopharmaceutical injection: known hypersensitivity to the active substance or to any of the excipients, renal impairment (GFR 30mL / min / 1.73m2), hepatic insufficiency or any other biological...
- Person suffering from claustrophobia.
- Pregnancy (for women of childbearing age, a urine pregnancy test will be performed on the day of the inclusion visit and the PET-MRI examination).
- Any symptoms or biological values suggestive of a systemic disorder (renal, hepatic, cardiovascular, pulmonary) or any other medical conditions that could interfere with the interpretation of test results or compromise...
- Person subject to a legal safeguard.
- Specific non-for AD-Y and PCA patients:
- Sudden appearance of cognitive deficits.
- Gait disturbances, convulsions, major behavior modification.
- Focal alterations to neurological examination, extrapyramidal signs, hallucinations, fluctuations. cognitive.
- Psychiatric, cerebrovascular, metabolic, inflammatory pathology.
- Specific non-for control people:
- Pathological neurological examination
- History of neurological disease (in particular ischemic stroke or neurodegenerative disease) or psychiatric illness (particularly severe depression, psychosis, or bipolar illness still requiring drug treatment at the...
- Physical affection that is serious or can interfere with cognitive functions.
The study team makes the final eligibility decision.
Where it's taking place
- Orsay, France
- Paris, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 40 years to 80 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Orsay, France; Paris, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.