- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00912886
Pregnenolone Sulfate an Early Marker of the Memory Loss in Alzheimer's Disease (STERMEM)
Neuroactive Steroids and Cognition in Humans: Pregnenolone Sulfate an Early Marker of the Memory Loss Associated With Alzheimer's Disease
Study Overview
Status
Conditions
Detailed Description
PREGS is a derivative of pregnenolone which the obligatory precursor of all steroid hormones originating from the gonads and adrenal glands. In rodents, PREGS has been demonstrated to improve memory performance in various behavioural tests. In humans, PREGS is one the most abundant circulating steroids. There are some indications about its decrease in blood during aging, and in brain samples from aged patients with AD, low concentrations of PREGS have been correlated with high levels of beta-amyloid peptide and phosphorylated tau protein. To date, a precise and rigorous evaluation of PREGS blood concentrations during aging is lacking and the relationship between these concentrations and the memory loss associated with AD has not been established.
Primary objective To show that plasma concentrations of PREGS are decreased in AD patients (" case ") compared to free-AD subjects (" controls "), matched for gender and age.
Secondary objectives
- To show that plasma concentrations of PREGS are inversely correlated with the severity of memory deficits in AD patients.
- To show that plasma concentrations of PREGS are correlated with the memory scores in the controls.
- To show that plasma concentrations of PREGS decrease in the controls.
- To search for a relationship between some of PREGS metabolites and age or the severity of memory deficits.
This is a case-control study that will comprise 200 subjects aged over 70 years, including 100 outpatients with mild to moderate AD and 100 AD-free volunteer controls matched on age and gender. These two groups will be stratified into age-sub-groups [70-74] [75-79] [80-84] [85-89] > 90 years and will include 10 men and 10 women per sub-group.
AD patients and controls will be enrolled and evaluated in the geriatric centres of 5 hospitals namely BICETRE, BROCA, PAUL BROUSSE, PITIE-SALPETRIERE and ROTHSCHILD. They will all be submitted to a clinical examination, biological analyses, cognitive tests and a brain magnetic resonance imaging scan. Blood will be collected from all subjects for steroid analysis by gas chromatography-mass spectrometry, a sensitive and accurate methodology that allows simultaneous quantification of several steroids in the same individual sample. PREGS and some of its metabolites will be identified and quantified at the "Institute medical of heath" (INSERM U788).
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Le Kremlin Bicêtre, France, 94275
- Assistance Publique - Hôpitaux de Paris Hôpital Bicêtre
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Le Kremlin Bicêtre, France, 94276
- Inserm Umr 788
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Paris, France, 75012
- AP-HP Hôpital Rothschild
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Paris, France, 75013
- Assistance Publique - Hôpitaux de Paris Hôpital Broca
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Paris, France, 75013
- Assistance Publique - Hôpitaux de Paris, Hôpital Pitié-Salpétrière
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Villejuif, France, 94800
- Assistance Publique - Hôpitaux de Paris, Hôpital Paul Brousse
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
- AD Patients will be recruited among the new patients from the consultations of the geriatric centres involved in the study
- Controls will be recruited from the consultations, associations of aged persons or among the relatives of the patient
Description
Inclusion Criteria:
- Subjects aged over 70 years who have signed informed consent for participation to the study and are affiliated to a social security regimen.
- For patients: subjects with probable AD according to the DSM-IV criteria and the NINCDS/ADRDA criteria and with mild to moderate probable AD: MMSE score> 15.
- For Controls: subjects without cognitive deficits on neuropsychological tests: scores of MMSE > 26 and of the 5 Word test equal to 10/10 and of the Clock Drawing test equal to 7/7.
Exclusion Criteria:
- Guardianship
- History of cerebrovascular disease, Parkinson's disease, other known dementia, epilepsy
- Major depression
- Serious sensory disorders; deficits in language & comprehension
- Serious heart or hepatic insufficiencies, renal or respiratory failures
- Unstable diabetes or endocrine disorders, thyroid dysfunction, cancer, inflammatory syndrome, malnutrition
- Cognitive training during the 6 previous months
- Medications: steroids (HRT, androgens, corticoids), anti-depressants, cholinesterase inhibitors, thyroid hormones, synthetic anti-thyroids
- Contraindications for MRI: metallic implants & claustrophobia
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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1: Case
Patients with early and moderate AD
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2: Controls
AD free volunteer-controls matched for gender and age
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Plasma concentrations of PREGS determined by GC-MS
Time Frame: At the day of diagnostic blood collection
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At the day of diagnostic blood collection
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Memory scores of the RL-RI test according to the GROBER and BUSCKE test
Time Frame: At the day of blood collection
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At the day of blood collection
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Plasma concentrations of PREGS metabolites
Time Frame: At the day of blood collection
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At the day of blood collection
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Collaborators and Investigators
Investigators
- Principal Investigator: Sebastien Weill-Engerer, MD, Assistance Publique - Hôpitaux de Paris Hôpital Rothschild
- Study Director: Yvette Akwa, PhD, INSERM U788
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- P071237
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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