Healthy Controls Without Orthostatic HypotensionNCT05821400
Cognitive Changes in Mild Cognitive Impairment
An observational study of Healthy Controls Without Orthostatic Hypotension, run by Fujian Medical University Union Hospital at 1 site in China.
Trial summary
Background: In recent years, the changes of cognitive function in mild cognitive impairment have attracted attention. Methods/design: We will follow up at 3. The primary outcome will be the measurement of cognitive function using neuropsychological assessment scales such as MOCA, MMSE, etc... Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- Healthy Controls Without Orthostatic Hypotension
- What is being tested?
- observational study
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2023to 30 Jun 2024
- 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 30 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Chinese who met the inclusion and exclusion criteria
Who may be able to join
- Clinically diagnosed mild cognitive impairment
Who cannot join
- Patients with orthostatic hypotension
- Patients with other neurological disorders.
- Pregnant or lactating women.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Fujian Medical University Union Hospital
Fuzhou, Fujian, 350000
Xiaodong Pan, 86218341, xieheyb@163.com
About this study
Official title: Cognitive Changes in Mild Cognitive Impairment Without Orthostatic Hypotension
Background: In recent years, the changes of cognitive function in mild cognitive impairment have attracted attention.
Methods/design: We will follow up at 3. The primary outcome will be the measurement of cognitive function using neuropsychological assessment scales such as MOCA, MMSE, etc... Minor variables will be included plasma biomarkers (Aβ, Tau, GFAP, etc.), multimodal brain electrophysiology (P300, VP300, heart rate variability, etc.), and neuroimaging indicators (NODDI).
- Being tested
- observational study
- Keywords
- cognition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
observational studyOther
observational study
| Study group | Role | What they receive |
|---|---|---|
| Healthy controls without orthostatic hypotension | Not described Receives: Other: observational study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Montreal Cognitive Assessment (MoCA) scores after 3 months.
The MOCA scale scores range from 0 to 30, with higher scores indicating better cognition
Measured: Participants will be followed up for 3 months after baseline.
Secondary outcomes (3)
Changes in Plasma amyloid protein levels after 3 months.
Plasma amyloid protein(ug/ml) is an important indicator of cognitive function.
Measured: Participants will be followed up for 3 months after baseline.
Changes in Plasma tau levels after 3 months.
Plasma tau(ug/ml) is an important indicator of cognitive function
Measured: Participants will be followed up for 3 months after baseline.
Changes in Blood pressure (mmHg) after 3 months.
An experienced physician will measure blood pressure on the right upper arm after the subject rest for 5 min, taking the average of the two measurements as the final result.
Measured: Participants will be followed up for 3 months after baseline.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2023
- Study start1 Mar 2023
- Primary completion30 Apr 2024 (estimated)
- Study completion30 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Healthy Controls Without Orthostatic HypotensionStudies 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
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fujian Medical University Union Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05821400
- Sponsor's protocol ID
- Cohort-MCI
- Status last verified
- Apr 2023
- First submitted
- 29 Sep 2022
- Last updated
- 20 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Petersen RC, Roberts RO, Knopman DS, Geda YE, Cha RH, Pankratz VS, Boeve BF, Tangalos EG, Ivnik RJ, Rocca WA. Prevalence of mild cognitive impairment is higher in men. The Mayo Clinic Study of Aging. Neurology. 2010 Sep 7;75(10):889-97. doi: 10.1212/WNL.0b013e3181f11d85.
PubMed 20820000Rabe-Jablonska J, Bienkiewicz W. [Anxiety disorders in the fourth edition of the classification of mental disorders prepared by the American Psychiatric Association: diagnostic and statistical manual of mental disorders (DMS-IV -- options book]. Psychiatr Pol. 1994 Mar-Apr;28(2):255-68. Polish.
PubMed 8208869
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Changes in Mild Cognitive Impairment Without Orthostatic Hypotension
- ClinicalTrials.gov ID
- NCT05821400
- Acronym / sponsor ID
- Cohort-MCI
- Keywords
- cognition
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Fujian Medical University Union HospitalUniversity, hospital or other
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 30 Apr 2024 (estimated)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 20 Apr 2023 (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.
Background: In recent years, the changes of cognitive function in mild cognitive impairment have attracted attention.
Methods/design: We will follow up at 3. The primary outcome will be the measurement of cognitive function using neuropsychological assessment scales such as MOCA, MMSE, etc... Minor variables will be included plasma biomarkers (Aβ, Tau, GFAP, etc.), multimodal brain electrophysiology (P300, VP300, heart rate variability, etc.), and neuroimaging indicators (NODDI).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy controls without orthostatic hypotension | – | Other: observational study |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Chinese who met the inclusion and exclusion criteria
Key inclusion criteria (1 listed)
- Clinically diagnosed mild cognitive impairment
Key exclusion criteria (3 listed)
- Patients with orthostatic hypotension
- Patients with other neurological disorders.
- Pregnant or lactating women.
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 |
|---|---|---|
| observational studyobservational study | Other | Healthy controls without orthostatic hypotension |
Primary outcome
Changes in Montreal Cognitive Assessment (MoCA) scores after 3 months.
Time frame: Participants will be followed up for 3 months after baseline.
The MOCA scale scores range from 0 to 30, with higher scores indicating better cognition
3 secondary outcomes
Changes in Plasma amyloid protein levels after 3 months.
Time frame: Participants will be followed up for 3 months after baseline.
Changes in Plasma tau levels after 3 months.
Time frame: Participants will be followed up for 3 months after baseline.
Changes in Blood pressure (mmHg) after 3 months.
Time frame: Participants will be followed up for 3 months after baseline.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2023.
- Background: PubMed 20820000Petersen RC, Roberts RO, Knopman DS, Geda YE, Cha RH, Pankratz VS, Boeve BF, Tangalos EG, Ivnik RJ, Rocca WA. Prevalence of mild cognitive impairment is higher in men. The Mayo Clinic Study of Aging. Neurology. 2010 Sep 7;75(10):889-97. doi: 10.1212/WNL.0b013e3181f11d85.
- Background: PubMed 8208869Rabe-Jablonska J, Bienkiewicz W. [Anxiety disorders in the fourth edition of the classification of mental disorders prepared by the American Psychiatric Association: diagnostic and statistical manual of mental disorders (DMS-IV -- options book]. Psychiatr Pol. 1994 Mar-Apr;28(2):255-68. Polish.
- Individual participant dataSharing planned: Yes
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.
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 Healthy Controls Without Orthostatic Hypotension, run by Fujian Medical University Union 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 1 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 20 Apr 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xiaodong Pan, Doctor (86218341, pxd77316@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Montreal Cognitive Assessment (MoCA) scores after 3 months. (time frame: Participants will be followed up for 3 months after baseline.). 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 NCT05821400, which also lists 2 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 20 Apr 2023.