BiomarkersSCD-CINCT04880252
Neuropsychological Indicators of SCD Progression
An observational study of Biomarkers and Cognitive Assessment, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
Trial summary
Some patients with subjective cognitive decline (SCD) progress to neurocognitive disorders (NCD), whereas others remain stable; however, the neuropsychological determinants of this progression have not been identified. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Biomarkers, Cognitive Assessment, Cognitive Decline
- How many people
- 80 participants
- Where
- 1 siteFrance
- Study dates
- 1 May 2019to 1 May 2020
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients consulting for SCD at a university medical center's memory center (Amiens, France) and who had undergone three or more neuropsychological assessments at least 6 months apart.
Who may be able to join
- patients who had been referred to the memory center at Amiens University Medical Center (Amiens, France).
- patients who had undergone three neuropsychological assessments at least 6 months apart, from 2005
- patients who met the criteria for SCD.
Who cannot join
- patients who didn't meet the criteria for SCD
Trial locations and contacts
1 site in 1 country.
About this study
Official title: In Individuals With Subjective Cognitive Decline, Age, Memory and Action Speed Scores at Baseline Predict Progression to Cognitive Impairment
Some patients with subjective cognitive decline (SCD) progress to neurocognitive disorders (NCD), whereas others remain stable; however, the neuropsychological determinants of this progression have not been identified. The investigators objective was to examine baseline neuropsychological indicators that could discriminate between people in whom the SCD progressed to a mild or major NCD and people in whom the SCD remained stable.
The investigators retrospectively included patients consulting for SCD at a university medical center's memory center (Amiens, France) and who had undergone three or more neuropsychological assessments at least 6 months apart. The relationship between domain-specific scores and the global cognitive score (GCS, as a function of final status (stable SCD vs. progression toward a mild or major NCD)) was examined using a generalized linear mixed model.
- Conditions
- Biomarkers, Cognitive Assessment, Cognitive Decline, Neurocognitive Disorders, Neurodegenerative Diseases, Subjective Cognitive Decline
- Keywords
- Biomarkers, Cognitive assessment, Cognitive decline, Neurocognitive disorders, Neurodegenerative diseases, Neuropsychological assessment, Risk of progression, Subjective cognitive decline
- Medical subject headings
- Cognitive Dysfunction, Neurocognitive Disorders, Neurodegenerative Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
Variation of neuropsychological indicators (global congnitive score) between NCD et SCD patients
subjective cognitive decline (SCD) neurocognitive disorders (NCD) neuropsychological indicators could discriminate between people in whom SCD progressed to a mild or major NCD and people in whom SCD remained stable.
A global cognitive score was created using all 5 tests : Alice Heim 4-I tests inductive reasoning ; Short-term verbal memory was assessed with a 20-word free-recall test; Two measures of verbal fluency were used: phonemic and semantic; Vocabulary was assessed using the Mill Hill Vocabulary test.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2021
- Study start1 May 2019
- Primary completion1 May 2020
- Study completion1 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for BiomarkersStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire, AmiensThe 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 only
- Time perspective
- Retrospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04880252
- Sponsor's protocol ID
- PI2019_843_0039
- Acronym
- SCD-CI
- Status last verified
- May 2021
- First submitted
- 4 May 2021
- Last updated
- 10 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Perron A, Roussel M, Wannepain-Despretz S, Barbay M, Devendeville A, Godefroy O, Andriuta D. In Individuals With Subjective Cognitive Decline, Age, Memory and Speed Scores at Baseline Predict Progression to Cognitive Impairment. Alzheimer Dis Assoc Disord. 2022 Oct-Dec 01;36(4):359-361. doi: 10.1097/WAD.0000000000000520. Epub 2022 Jul 19.
PubMed 35867966
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- In Individuals With Subjective Cognitive Decline, Age, Memory and Action Speed Scores at Baseline Predict Progression to Cognitive Impairment
- ClinicalTrials.gov ID
- NCT04880252
- Acronym / sponsor ID
- SCD-CI / PI2019_843_0039
- Conditions
- Biomarkers, Cognitive Assessment, Cognitive Decline, Neurocognitive Disorders, Neurodegenerative Diseases, Subjective Cognitive Decline
- Keywords
- Biomarkers, Cognitive assessment, Cognitive decline, Neurocognitive disorders, Neurodegenerative diseases, Neuropsychological assessment, Risk of progression, Subjective cognitive decline
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Study start
- 1 May 2019 (actual)
- Primary completion
- 1 May 2020 (actual)
- Study completion
- 1 May 2020 (actual)
- First posted
- 10 May 2021 (actual)
- 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.
Some patients with subjective cognitive decline (SCD) progress to neurocognitive disorders (NCD), whereas others remain stable; however, the neuropsychological determinants of this progression have not been identified. The investigators objective was to examine baseline neuropsychological indicators that could discriminate between people in whom the SCD progressed to a mild or major NCD and people in whom the SCD remained stable.
The investigators retrospectively included patients consulting for SCD at a university medical center's memory center (Amiens, France) and who had undergone three or more neuropsychological assessments at least 6 months apart. The relationship between domain-specific scores and the global cognitive score (GCS, as a function of final status (stable SCD vs. progression toward a mild or major NCD)) was examined using a generalized linear mixed model.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients consulting for SCD at a university medical center's memory center (Amiens, France) and who had undergone three or more neuropsychological assessments at least 6 months apart.
Key inclusion criteria (3 listed)
- patients who had been referred to the memory center at Amiens University Medical Center (Amiens, France).
- patients who had undergone three neuropsychological assessments at least 6 months apart, from 2005
- patients who met the criteria for SCD.
Key exclusion criteria (1 listed)
- patients who didn't meet the criteria for SCD
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
Variation of neuropsychological indicators (global congnitive score) between NCD et SCD patients
Time frame: one year
subjective cognitive decline (SCD) neurocognitive disorders (NCD) neuropsychological indicators could discriminate between people in whom SCD progressed to a mild or major NCD and people in whom SCD remained stable. A global cognitive score was created using all 5 tests : Alice Heim 4-I tests inductive reasoning ; Short-term verbal memory was assessed with a 20-word free-recall test; Two measures of verbal fluency were used: phonemic and semantic; Vocabulary was assessed using the Mill Hill Vocabulary test.
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 10 May 2021.
- Derived from this study: PubMed 35867966Perron A, Roussel M, Wannepain-Despretz S, Barbay M, Devendeville A, Godefroy O, Andriuta D. In Individuals With Subjective Cognitive Decline, Age, Memory and Speed Scores at Baseline Predict Progression to Cognitive Impairment. Alzheimer Dis Assoc Disord. 2022 Oct-Dec 01;36(4):359-361. doi: 10.1097/WAD.0000000000000520. Epub 2022 Jul 19.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Biomarkers and Cognitive Assessment, run by Centre Hospitalier Universitaire, Amiens at 1 site 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 1 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 10 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Variation of neuropsychological indicators (global congnitive score) between NCD et SCD patients (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04880252, which also lists 1 linked publication.
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 10 May 2021.