Status:
COMPLETED
Pregnenolone Sulfate an Early Marker of the Memory Loss in Alzheimer's Disease
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Alzheimer Disease
Eligibility:
All Genders
70+ years
Brief Summary
The steroid pregnenolone sulfate (PREGS) may be one of the factors responsible for the memory decline related to normal aging or associated with Alzheimer's disease (AD). The purpose of this study is ...
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 p...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2009
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 1 2011
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT00912886
Start Date
September 1 2009
End Date
September 1 2011
Last Update
April 11 2013
Active Locations (6)
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1
Assistance publique - Hôpitaux de Paris Hôpital Bicêtre
Le Kremlin-Bicêtre, France, 94275
2
Inserm Umr 788
Le Kremlin-Bicêtre, France, 94276
3
AP-HP Hôpital Rothschild
Paris, France, 75012
4
Assistance Publique - Hôpitaux de Paris Hôpital Broca
Paris, France, 75013