Alzheimer DiseaseNCT03447613
Retinal Nerve Fiber Layer Thickness and Cerebrospinal Fluid Aβ/Tau
An observational study of Alzheimer Disease, run by Shanghai 10th People's Hospital at 1 site in China.
Trial summary
To test the hypothesis that retinal nerve fiber layer (RNFL) thickness is correlated with Aβ and Tau concentration of cerebrospinal fluid (CSF) in an older population. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Alzheimer Disease
- What is being tested?
- surgery
- Type of treatment
- Surgery or procedure
- How many people
- 86 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2013to 31 Dec 2014
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: A total of 300 old adults who were scheduled to have elective total hip or knee replacement surgery, ureteroscopic lithotripsy and transurethral resection of the prostate at the Shanghai 10th People's Hospital were asked to participate in this study. A total of 104 participants were enrolled from August 2013 to December 2014, and the data from 86 participants were finally included in the study.
Who may be able to join
- 50 years old or older;
- five years or more of education and scores of MMSE ≥ 24 points;
- Chinese as their first language;
- Having spinal anesthesia.
Who cannot join
- prior diagnoses of neurologic diseases, e.g., dementia, Parkinson's diseases, multiple sclerosis or stroke according to DSM-IV;
- history of mental disorders (e.g., major depressive disorder and schizophrenia) diagnosed according to DSM-IV;
- known diseases contributing to the retina pathologies, e.g., diabetes, glaucoma or increased intraocular pressure (more than 22 mmHg), cataract, and macular degeneration and hypermyopia;
- unwillingness to comply with the cognitive assessments;
- ungradable images of OCT.
Trial locations and contacts
1 site in 1 country.
China1 site
Shanghai 10th People's Hospital
Shanghai, Shanghai Municipality, 200072
About this study
Official title: Association of Retinal Nerve Fiber Layer (RNFL) Thickness With Cerebrospinal Fluid Aβ and Tau Concentration
To test the hypothesis that retinal nerve fiber layer (RNFL) thickness is correlated with Aβ and Tau concentration of cerebrospinal fluid (CSF) in an older population.
Read the detailed description
retinal nerve fiber layer (RNFL) thickness changing has been reported in Alzheimer's Disease (AD) patients at an early stage, and has been demonstrated as a potential biomarker able to predict cognitive deterioration (Hinton DR et al., N Engl J Med 1986; London A et al. Nat Rev Neurol 2013; Chang LY et al., Alzheimers Dement 2014). However, whether RNFL thickness is correlated with cerebrospinal fluid (CSF) features of AD pathogenesis (e.g., Aβ and Tau) remains unclear. The investigators thus conducted this observational cohort study to test the correlation between RNFL thickness changing and CSF, to further validate RNFL as a potential AD biomarker.
- Conditions
- Alzheimer Disease
- Being tested
- surgery
- Keywords
- retinal nerve fiber layer, cerebrospinal fluid Aβ and Tau
- Medical subject headings
- Alzheimer Disease, Pick Disease of the Brain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
surgeryProcedure or surgery
All participants were scheduled to have elective total hip or knee replacement surgery, ureteroscopic lithotripsy and transurethral resection of the prostate under spinal anesthesia at the Shanghai 10th People's Hospital. After 5 years, the investigaors will follow up the participants including cognitive functions, PET-CT, thickness of Retinal Nerve Fiber Layer.
| Study group | Role | What they receive |
|---|---|---|
| elderly participants with surgery | The studied cohort were participants 50 years old or older, without a diagnosis of dementia, and scheduled to have orthopedic or urological surgery under spinal anesthesia at Shanghai 10th People's Hospital. Receives: Procedure: surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Specific cognitive function
Neuropsychological test battery to assess specific cognitive function, including immediate memory, visuospatial memory and executive function.
Measured: Within one week before surgery
Secondary outcomes (4)
retinal nerve fiber layer (RNFL) thickness
Optical coherence tomography (Carl Zeiss Meditec, Inc., Dublin, CA, USA) to measure RNFL thickness
Measured: Within one week before surgery
Cerebrospinal fluid (CSF) Aβ concentration
ELISA kits (Aβ40: Cat. # 292-62301; Aβ42: Cat. # 296-64401, Wako, Richmond, VA) to measure Aβ concentration
Measured: During the spinal anesthesia before the administration of the local anesthetic.
Cerebrospinal fluid (CSF) Tau concentration
ELISA kits (Tau: Cat. # KHB0041, Invitrogen, San Francisco, CA) to measure Aβ concentration
Measured: During the spinal anesthesia before the administration of the local anesthetic.
Global cognitive state
Mini-Mental State Examination (MMSE) to assess global cognitive function
Measured: Within one week before surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2018
- Study start1 Aug 2013
- Primary completion31 Dec 2014
- Study completion31 Dec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai 10th People's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Massachusetts General Hospital
- Responsible party
- Principal investigator, Yuan Shen, MD, PhD, Shanghai 10th People's Hospital
- Investigators
- Yuan Shen, MD, PhD, Principal investigator, Shanghai 10th People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03447613
- Sponsor's protocol ID
- dsyy001
- Status last verified
- Nov 2018
- First submitted
- 17 Feb 2018
- Last updated
- 30 Nov 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
London A, Benhar I, Schwartz M. The retina as a window to the brain-from eye research to CNS disorders. Nat Rev Neurol. 2013 Jan;9(1):44-53. doi: 10.1038/nrneurol.2012.227. Epub 2012 Nov 20.
PubMed 23165340Chang LY, Lowe J, Ardiles A, Lim J, Grey AC, Robertson K, Danesh-Meyer H, Palacios AG, Acosta ML. Alzheimer's disease in the human eye. Clinical tests that identify ocular and visual information processing deficit as biomarkers. Alzheimers Dement. 2014 Mar;10(2):251-61. doi: 10.1016/j.jalz.2013.06.004. Epub 2013 Sep 5.
PubMed 24011928Hinton DR, Sadun AA, Blanks JC, Miller CA. Optic-nerve degeneration in Alzheimer's disease. N Engl J Med. 1986 Aug 21;315(8):485-7. doi: 10.1056/NEJM198608213150804.
PubMed 3736630
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association of Retinal Nerve Fiber Layer (RNFL) Thickness With Cerebrospinal Fluid Aβ and Tau Concentration
- ClinicalTrials.gov ID
- NCT03447613
- Acronym / sponsor ID
- dsyy001
- Conditions
- Alzheimer Disease
- Keywords
- retinal nerve fiber layer, cerebrospinal fluid Aβ and Tau
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Shanghai 10th People's HospitalUniversity, hospital or other
- Collaborators
- Massachusetts General Hospital
- Study start
- 1 Aug 2013 (actual)
- Primary completion
- 31 Dec 2014 (actual)
- Study completion
- 31 Dec 2014 (actual)
- First posted
- 27 Feb 2018 (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.
To test the hypothesis that retinal nerve fiber layer (RNFL) thickness is correlated with Aβ and Tau concentration of cerebrospinal fluid (CSF) in an older population.
Detailed description
retinal nerve fiber layer (RNFL) thickness changing has been reported in Alzheimer's Disease (AD) patients at an early stage, and has been demonstrated as a potential biomarker able to predict cognitive deterioration (Hinton DR et al., N Engl J Med 1986; London A et al. Nat Rev Neurol 2013; Chang LY et al., Alzheimers Dement 2014). However, whether RNFL thickness is correlated with cerebrospinal fluid (CSF) features of AD pathogenesis (e.g., Aβ and Tau) remains unclear. The investigators thus conducted this observational cohort study to test the correlation between RNFL thickness changing and CSF, to further validate RNFL as a potential AD biomarker.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| elderly participants with surgery | – | Procedure: surgeryThe studied cohort were participants 50 years old or older, without a diagnosis of dementia, and scheduled to have orthopedic or urological surgery under spinal anesthesia at Shanghai 10th People's Hospital. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- A total of 300 old adults who were scheduled to have elective total hip or knee replacement surgery, ureteroscopic lithotripsy and transurethral resection of the prostate at the Shanghai 10th People's Hospital were asked to participate in this study. A total of 104 participants were enrolled from August 2013 to December 2014, and the data from 86 participants were finally included in the study.
Key inclusion criteria (4 listed)
- 50 years old or older;
- five years or more of education and scores of MMSE ≥ 24 points;
- Chinese as their first language;
- Having spinal anesthesia.
Key exclusion criteria (5 listed)
- prior diagnoses of neurologic diseases, e.g., dementia, Parkinson's diseases, multiple sclerosis or stroke according to DSM-IV;
- history of mental disorders (e.g., major depressive disorder and schizophrenia) diagnosed according to DSM-IV;
- known diseases contributing to the retina pathologies, e.g., diabetes, glaucoma or increased intraocular pressure (more than 22 mmHg), cataract, and macular degeneration and hypermyopia;
- unwillingness to comply with the cognitive assessments;
- ungradable images of OCT.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| surgeryAll participants were scheduled to have elective total hip or knee replacement surgery, ureteroscopic lithotripsy and transurethral resection of the prostate under spinal anesthesia at the Shanghai 10th People's Hospital. After 5 years, the investigaors will follow up the participants including cognitive functions, PET-CT, thickness of Retinal Nerve Fiber Layer. | Procedure or surgery | elderly participants with surgery |
Primary outcome
Specific cognitive function
Time frame: Within one week before surgery
Neuropsychological test battery to assess specific cognitive function, including immediate memory, visuospatial memory and executive function.
4 secondary outcomes
retinal nerve fiber layer (RNFL) thickness
Time frame: Within one week before surgery
Cerebrospinal fluid (CSF) Aβ concentration
Time frame: During the spinal anesthesia before the administration of the local anesthetic.
Cerebrospinal fluid (CSF) Tau concentration
Time frame: During the spinal anesthesia before the administration of the local anesthetic.
Global cognitive state
Time frame: Within one week before surgery
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 30 Nov 2018.
- Results publication: PubMed 23165340London A, Benhar I, Schwartz M. The retina as a window to the brain-from eye research to CNS disorders. Nat Rev Neurol. 2013 Jan;9(1):44-53. doi: 10.1038/nrneurol.2012.227. Epub 2012 Nov 20.
- Results publication: PubMed 24011928Chang LY, Lowe J, Ardiles A, Lim J, Grey AC, Robertson K, Danesh-Meyer H, Palacios AG, Acosta ML. Alzheimer's disease in the human eye. Clinical tests that identify ocular and visual information processing deficit as biomarkers. Alzheimers Dement. 2014 Mar;10(2):251-61. doi: 10.1016/j.jalz.2013.06.004. Epub 2013 Sep 5.
- Results publication: PubMed 3736630Hinton DR, Sadun AA, Blanks JC, Miller CA. Optic-nerve degeneration in Alzheimer's disease. N Engl J Med. 1986 Aug 21;315(8):485-7. doi: 10.1056/NEJM198608213150804.
- Individual participant dataSharing planned: Undecided
Related trials for Alzheimer Disease
RecruitingObservational study
PET Imaging in the Baltimore Longitudinal Study of Aging (BLSA)
Aging
RecruitingPhase 3
A Phase 3 Study to Evaluate the Safety and Efficacy of KarXT + KarX-EC for the Treatment of Agitation Associated With Alzheimer's Disease
Alzheimer's Disease
RecruitingObservational study
Development, Validation and Normative Data of the Italian Battery for the Recognition of Famous Faces (FAME)
Stroke, Alzheimer s Disease
RecruitingPhase 2
Neuroplasticity Enhancement From Cognitive Training Reinforced by Psilocybin
Alzheimer's Disease
Not yet recruiting
Assessing Treatment With High-phenolic EVOO Supplements for Neurovascular Activity
Mild Cognitive Impairment (MCI)
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.
Yuan Shen, MD, PhD principal investigator
Shanghai 10th People's Hospital
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 Alzheimer Disease, run by Shanghai 10th People's Hospital at 1 site in China.
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 4 inclusion and 5 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 30 Nov 2018. 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 China. 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?
Specific cognitive function (time frame: Within one week before surgery). 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 NCT03447613, which also lists 3 linked publications.
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 30 Nov 2018.