Alzheimer DiseaseSTERMEMNCT00912886
Pregnenolone Sulfate an Early Marker of the Memory Loss in Alzheimer's Disease
An observational study of Alzheimer Disease, run by Assistance Publique - Hôpitaux de Paris at 6 sites in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 70 years and olderHealthy volunteers can take part
- Conditions the study is for
- Alzheimer Disease
- How many people
- 90 participants
- Where
- 6 sitesFrance
- Study dates
- Sep 2009to Sep 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
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
Who may be able to join
- 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.
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
France6 sites
Assistance publique - Hôpitaux de Paris Hôpital Bicêtre
Le Kremlin-Bicêtre, 94275
Inserm Umr 788
Le Kremlin-Bicêtre, 94276
AP-HP Hôpital Rothschild
Paris, 75012
Assistance Publique - Hôpitaux de Paris Hôpital Broca
Paris, 75013
Assistance Publique - Hôpitaux de Paris, Hôpital Pitié-Salpétrière
Paris, 75013
Assistance Publique - Hôpitaux de Paris, Hôpital Paul Brousse
Villejuif, 94800
About this study
Official title: Neuroactive Steroids and Cognition in Humans: Pregnenolone Sulfate an Early Marker of the Memory Loss Associated With Alzheimer's Disease
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.
Read the 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).
- Conditions
- Alzheimer Disease
- Keywords
- alzheimer, memory, neurosteroids
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1: Case | Patients with early and moderate AD | |
| 2: Controls | AD free volunteer-controls matched for gender and age |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma concentrations of PREGS determined by GC-MS
Measured: At the day of diagnostic blood collection
Secondary outcomes (2)
Memory scores of the RL-RI test according to the GROBER and BUSCKE test
Measured: At the day of blood collection
Plasma concentrations of PREGS metabolites
Measured: At the day of blood collection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2009 (estimated)
- Study startSep 2009
- Primary completionSep 2011
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sebastien Weill-Engerer, MD, Principal investigator, Assistance Publique - Hôpitaux de Paris Hôpital RothschildYvette Akwa, PhD, Study director, INSERM U788
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00912886
- Sponsor's protocol ID
- P071237
- Acronym
- STERMEM
- Status last verified
- Apr 2013
- First submitted
- 2 Jun 2009
- Last updated
- 11 Apr 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuroactive Steroids and Cognition in Humans: Pregnenolone Sulfate an Early Marker of the Memory Loss Associated With Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT00912886
- Acronym / sponsor ID
- STERMEM / P071237
- Conditions
- Alzheimer Disease
- Keywords
- alzheimer, memory, neurosteroids
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Sep 2009
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 3 Jun 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1: Case | – | –Patients with early and moderate AD |
| 2: Controls | – | –AD free volunteer-controls matched for gender and age |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- 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
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Plasma concentrations of PREGS determined by GC-MS
Time frame: At the day of diagnostic blood collection
2 secondary outcomes
Memory scores of the RL-RI test according to the GROBER and BUSCKE test
Time frame: At the day of blood collection
Plasma concentrations of PREGS metabolites
Time frame: At the day of blood collection
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sebastien Weill-Engerer, MD principal investigator
Assistance Publique - Hôpitaux de Paris Hôpital Rothschild
Yvette Akwa, PhD study director
INSERM U788
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Alzheimer Disease, run by Assistance Publique - Hôpitaux de Paris at 6 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasma concentrations of PREGS determined by GC-MS (time frame: At the day of diagnostic blood collection). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2013.