Pregnenolone Sulfate an Early Marker of the Memory Loss in Alzheimer's Disease

NCT00912886 | Completed

• 1 other identifier: P071237
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 6

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 to determine whether plasma levels of PREGS are decreased patients with at mild to moderate AD compared with AD-free control subjects matched for gender and age and to see whether they are inversely correlated with the severity of memory deficits in AD patients. The hypothesis is that blood levels of PREGS are decreased with advanced age and with the stage of AD that would be positively correlated with memory deficits. Therefore PREGS could be considered as an early marker of the memory deficits in AD.

Conditions

Alzheimer Disease

Keywords

alzheimer; memory; neurosteroids

Outcome Measures

Primary Outcomes (1)

• Plasma concentrations of PREGS determined by GC-MS

  At the day of diagnostic blood collection

Secondary Outcomes (2)

• Memory scores of the RL-RI test according to the GROBER and BUSCKE test

  At the day of blood collection

• Plasma concentrations of PREGS metabolites

  At the day of blood collection

Study Arms (2)

1: Case

Patients with early and moderate AD

2: Controls

AD free volunteer-controls matched for gender and age

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (6)

Assistance publique - Hôpitaux de Paris Hôpital Bicêtre

Le Kremlin-Bicêtre, 94275, France

Location

Inserm Umr 788

Le Kremlin-Bicêtre, 94276, France

Location

AP-HP Hôpital Rothschild

Paris, 75012, France

Location

Assistance Publique - Hôpitaux de Paris Hôpital Broca

Paris, 75013, France

Location

Assistance Publique - Hôpitaux de Paris, Hôpital Pitié-Salpétrière

Paris, 75013, France

Location

Assistance Publique - Hôpitaux de Paris, Hôpital Paul Brousse

Villejuif, 94800, France

Location

Biospecimen

Retention: SAMPLES WITH DNA

Plasma and serum from AD patients and from Controls

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Sebastien Weill-Engerer, MD

  Assistance Publique - Hôpitaux de Paris Hôpital Rothschild

  PRINCIPAL INVESTIGATOR

• Yvette Akwa, PhD

  INSERM U788

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2009
• First Posted: June 3, 2009
• Study Start: September 1, 2009
• Primary Completion: September 1, 2011
• Study Completion: September 1, 2011
• Last Updated: April 11, 2013

Record last verified: 2013-04

Locations

FR (6)