Aging Related Cognitive DeclinePhase 1NCT05041088
Omega 3 Oil: Aging-Related Cognitive Decline
A Phase 1 study testing ProdromeNeuro Plasmalogen in people with Aging Related Cognitive Decline, run by Neurological Associates of West Los Angeles.
Trial summary
Aging-related cognitive decline may be affected by brain cholesterol and the health of cell membranes. Certain nutritional supplements have been proposed to support membrane health, and there is increasing interest in plasmalogens and Omega-3 derived oil supplements to support brain health among older adults. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Aging Related Cognitive Decline
- What is being tested?
- ProdromeNeuro Plasmalogen
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 20 Jun 2023to 20 Nov 2023
- Phase
- Phase 1
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Evidence of a degenerative process
- Clinical Dementia Rating (CDR) score indicating mild cognitive impairment (CDR = 0.5), mild dementia (CDR = 1) through moderate dementia (CDR = 2)
Who cannot join
- Subjects unable to give informed assent
- Cognitive decline clearly related to an acute illness
- Advanced terminal illness
- Any active cancer or chemotherapy
- Any other neoplastic illness or illness characterized by neovascularity or angiopathy
- Subjects previously taking plasmalogen supplementation prior to study enrollment
Trial locations and contacts
No sites are listed yet.
About this study
Official title: ProdromeNeuro: A Phase I Study of Omega 3 Oil Nutritional Supplementation for Aging-Related Cognitive Decline
Aging-related cognitive decline may be affected by brain cholesterol and the health of cell membranes. Certain nutritional supplements have been proposed to support membrane health, and there is increasing interest in plasmalogens and Omega-3 derived oil supplements to support brain health among older adults. Plasmalogens are compounds found in neural cell membranes that are connected to cholesterol processing. Neural cells that have low plasmalogens have shown an inability to process cholesterol properly. Recent research suggests that abnormalities in cholesterol processing and low levels of plasmalogen may play a role in age-related cognitive decline.
The product being investigated in this study is the ProdromeNeuro Omega 3 oil nutritional supplement. This product contains naturally occurring fatty acids in higher concentrations than similar products that are commercially available. The purpose of this research study is to better understand the effects of ProdromeNeuro Omega-3 nutritional supplementation among participants with age-related cognitive decline. It is hoped that taking this product over the course of 4 months will result in improved plasmalogen levels, brain connectivity seen on advanced brain imaging, as well as improved cognitive assessment measurements.
- Conditions
- Aging Related Cognitive Decline
- Being tested
- ProdromeNeuro Plasmalogen
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProdromeNeuro PlasmalogenDietary supplement
The product being investigated in this study is the ProdromeNeuro Omega 3 oil nutritional supplement. This product contains naturally occurring fatty acids in higher concentrations than similar products that are commercially available. The purpose of this research study is to better understand the effects of ProdromeNeuro Omega-3 nutritional supplementation among participants with age-related cognitive decline.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group (ALL participants) | Experimental | This group will be taking plamalogen supplement (ProdromeNeuro) and be followed through the study with neuropsychological testing, serology, and follow up MRI data. They will be administered 2mL per day for 6 months Receives: Dietary Supplement: ProdromeNeuro Plasmalogen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in ProdromeScan Blood Test
serological testing kit for plasmalogen levels
Measured: Change monitored from baseline to 6 month time point (also assessed for change at the end of each month is this time period)
Secondary outcomes (8)
Change in 9-Hole Pegboard Task (9-HPT)
A validated assessment for fine motor skills, the 9-HPT involves having a participant move 9 pegs individually from starting position to 9 separate peg-holes, as quickly as possible, and to immediately return the 9 pegs to the starting position upon filling the final peg-hole. This is performed separately for each hand. The score is the time (seconds/milliseconds) that it takes to complete the task, recorded separately for dominant and non-dominant hands. The minimum detectable change is 2.6 seconds for the dominant hand and 1.3 seconds for the non-dominant hand.
Measured: Change monitored from baseline to 6 month time point (also assessed for change at the end of each month is this time period)
Change in Montreal Cognitive Assessment (MoCA)
The MoCA evaluates frontal-executive functions (e.g., verbal abstraction and mental calculation), language (e.g., confrontation naming, phonemic fluency), orientation (e.g., person, place, date, day of the week, and time), visuospatial construction (e.g., simple figure copy), divided visual attention, and immediate and delayed memory of unstructured information. MoCA scores range from 0-30 possible points; 26 or greater is considered to reflect normal cognitive status.
Measured: Change monitored from baseline to 6 month time point (also assessed for change at the end of each month is this time period)
Change in Timed 25-foot Walk Test (T25-FW)
The T25FW is a clinical tool that evaluates patients for quantitative mobility and leg function performance test in a timed, 25-foot walk. Scoring for this task is the average number of steps (from first step to the first heel-strike after the finish line) and time taken (seconds/milliseconds) of two trials. Minimally clinically important difference (MCID) is 20% improvement in time taken and/or number of steps taken to complete.
Measured: Change monitored from baseline to 6 month time point (also assessed for change at the end of each month is this time period)
Change in Timed 25-foot Walk Test Steps (T25-FW)
The T25FW is a clinical tool that evaluates patients for quantitative mobility and leg function performance test in a timed, 25-foot walk. Scoring for this task is the average number of steps (from first step to the first heel-strike after the finish line) of two trials. Minimally clinically important difference (MCID) is 20% improvement in number of steps taken to complete.
Measured: Change monitored from baseline to 6 month time point (also assessed for change at the end of each month is this time period)
Change in 30-Second Sit Stand (30CST)
The 30-second chair stand involves recording the number of times that a person can complete a full stand in 30 seconds. This measure assesses functional lower extremity strength in older adults. The participant is instructed to complete as many full stands as possible within 30 seconds, starting in a seated position in the middle of an armless chair. The participant is instructed to fully sit between each stand. The tester silently counts the completion of each correct stand, and the score is the total number of stands within 30 seconds. The minimum clinically important difference (MCID) is 2 full stands per 30 second testing.
Measured: Change monitored from baseline to 6 month time point (also assessed for change at the end of each month is this time period)
Change in Quick Dementia Rating Scale (QDRS) used to calculate a Clinical Dementia Rating (CDR) scale
The Quick Dementia Rating Scale (QDRS) is an interview-based tool administered by study officials to participants' caregivers used to obtain observations from a consistent source. The QDRS form consists of 10 categorical questions (5 cognitive, 5 functional), each with 5 detailed options depicting the level of impairment as either 0 (normal), 0.5 (mild/inconsistent impairment), 1 (mild/consistent impairment), 2 (moderate impairment), or 3 (severe impairment). Based on the conversion table outlined in Dr. James Galvin's research (2015), total QDRS scores were converted to Clinical Dementia Rating (CDR) scale levels ranging from 0 (normal aging), 0.5 (mild cognitive impairment), 1 (mild dementia), 2 (moderate dementia), and 3 (severe dementia).
Measured: Change monitored from baseline to 6 month time point (also assessed for change at the end of each month is this time period)
Global Rating of Change (GRC)
GThe GRC consists of a single likert-scale ranging from "-5" (very much worse) to "0" (neutral/no change) to "5" (very much better). The GRC is obtained in an interview format to assess a patient's perceived change in status following a treatment. A score that is at least 2 or greater is considered to indicate clinically significant change.
Measured: Assessed at 6 month time point (reflecting on the study)
Change in Timed 25-foot Walk Test Speed (T25-FW)
The T25FW is a clinical tool that evaluates patients for quantitative mobility and leg function performance test in a timed, 25-foot walk. Scoring for this task is the average time to complete walk (in seconds/milliseconds) (from first step to the first heel-strike after the finish line) of two trials. Minimally clinically important difference (MCID) is 20% improvement in time taken to complete.
Measured: Change monitored from baseline to 6 month time point (also assessed for change at the end of each month is this time period)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2021
- Study start20 Jun 2023 (estimated)
- Primary completion20 Sep 2023 (estimated)
- Study completion20 Nov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aging Related Cognitive DeclineStudies 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
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Neurological Associates of West Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- Prodrome Sciences Inc
- Responsible party
- Sponsor
- Investigators
- Kennedy Mahdavi, BS, Study director, Neurological AssociatesSheldon Jordan, MD, Principal investigator, Neurological Associates
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05041088
- Sponsor's protocol ID
- Plasmalogen2.0
- Status last verified
- Jul 2022
- First submitted
- 30 Aug 2021
- Last updated
- 22 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ProdromeNeuro: A Phase I Study of Omega 3 Oil Nutritional Supplementation for Aging-Related Cognitive Decline
- ClinicalTrials.gov ID
- NCT05041088
- Acronym / sponsor ID
- Plasmalogen2.0
- Conditions
- Aging Related Cognitive Decline
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Neurological Associates of West Los AngelesUniversity, hospital or other
- Collaborators
- Prodrome Sciences Inc
- Study start
- 20 Jun 2023 (estimated)
- Primary completion
- 20 Sep 2023 (estimated)
- Study completion
- 20 Nov 2023 (estimated)
- First posted
- 10 Sep 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.
Aging-related cognitive decline may be affected by brain cholesterol and the health of cell membranes. Certain nutritional supplements have been proposed to support membrane health, and there is increasing interest in plasmalogens and Omega-3 derived oil supplements to support brain health among older adults. Plasmalogens are compounds found in neural cell membranes that are connected to cholesterol processing. Neural cells that have low plasmalogens have shown an inability to process cholesterol properly. Recent research suggests that abnormalities in cholesterol processing and low levels of plasmalogen may play a role in age-related cognitive decline.
The product being investigated in this study is the ProdromeNeuro Omega 3 oil nutritional supplement. This product contains naturally occurring fatty acids in higher concentrations than similar products that are commercially available. The purpose of this research study is to better understand the effects of ProdromeNeuro Omega-3 nutritional supplementation among participants with age-related cognitive decline. It is hoped that taking this product over the course of 4 months will result in improved plasmalogen levels, brain connectivity seen on advanced brain imaging, as well as improved cognitive assessment measurements.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental Group (ALL participants) | Experimental | Dietary Supplement: ProdromeNeuro PlasmalogenThis group will be taking plamalogen supplement (ProdromeNeuro) and be followed through the study with neuropsychological testing, serology, and follow up MRI data. They will be administered 2mL per day for 6 months |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Evidence of a degenerative process
- Clinical Dementia Rating (CDR) score indicating mild cognitive impairment (CDR = 0.5), mild dementia (CDR = 1) through moderate dementia (CDR = 2)
Key exclusion criteria (6 listed)
- Subjects unable to give informed assent
- Cognitive decline clearly related to an acute illness
- Advanced terminal illness
- Any active cancer or chemotherapy
- Any other neoplastic illness or illness characterized by neovascularity or angiopathy
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 |
|---|---|---|
| ProdromeNeuro PlasmalogenThe product being investigated in this study is the ProdromeNeuro Omega 3 oil nutritional supplement. This product contains naturally occurring fatty acids in higher concentrations than similar products that are commercially available. The purpose of this research study is to better understand the effects of ProdromeNeuro Omega-3 nutritional supplementation among participants with age-related cognitive decline. | Dietary supplement | Experimental Group (ALL participants) |
Primary outcome
Change in ProdromeScan Blood Test
Time frame: Change monitored from baseline to 6 month time point (also assessed for change at the end of each month is this time period)
serological testing kit for plasmalogen levels
8 secondary outcomes
Change in 9-Hole Pegboard Task (9-HPT)
Time frame: Change monitored from baseline to 6 month time point (also assessed for change at the end of each month is this time period)
Change in Montreal Cognitive Assessment (MoCA)
Time frame: Change monitored from baseline to 6 month time point (also assessed for change at the end of each month is this time period)
Change in Timed 25-foot Walk Test (T25-FW)
Time frame: Change monitored from baseline to 6 month time point (also assessed for change at the end of each month is this time period)
Change in Timed 25-foot Walk Test Steps (T25-FW)
Time frame: Change monitored from baseline to 6 month time point (also assessed for change at the end of each month is this time period)
Change in 30-Second Sit Stand (30CST)
Time frame: Change monitored from baseline to 6 month time point (also assessed for change at the end of each month is this time period)
Change in Quick Dementia Rating Scale (QDRS) used to calculate a Clinical Dementia Rating (CDR) scale
Time frame: Change monitored from baseline to 6 month time point (also assessed for change at the end of each month is this time period)
Global Rating of Change (GRC)
Time frame: Assessed at 6 month time point (reflecting on the study)
Change in Timed 25-foot Walk Test Speed (T25-FW)
Time frame: Change monitored from baseline to 6 month time point (also assessed for change at the end of each month is this time period)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2022.
- Individual participant dataSharing planned: No
Related trials for Aging Related Cognitive Decline
RecruitingObservational study
China HEalthy Aging and Dementia Study (HEAD)
Alzheimer Disease (AD), Mild Cognitive Impairment (MCI)
Not yet recruiting
High-Velocity Resistance Training for Brain Blood Flow and Cognitive Function in Older Adults
At Risk for AD-dementia, With Subjective Cognitive Decline, At Risk for Cognitive Decline
Recruiting
Epigenetic Enhancement of Cognitive Training in Aging Mood and Schizophrenia Spectrum Disorder Populations
Bipolar Disorder (BD), Depression - Major Depressive Disorder
Active, not recruitingObservational study
The Dortmund Vital Study: Impact of Biological and Lifestyle Factors on Cognitive Performace and Work Ability
Age-related Cognitive Decline
Active, not recruiting
Promoting Goals-of-Care Discussions for Patients With Memory Problems and Their Caregivers
Dementia, Dementia, Vascular
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.
Kennedy Mahdavi, BS study director
Neurological Associates
Sheldon Jordan, MD principal investigator
Neurological Associates
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ProdromeNeuro Plasmalogen in people with Aging Related Cognitive Decline, run by Neurological Associates of West Los Angeles.
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 2 inclusion and 6 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 22 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Maggie Zielinski, BS (3108295968 ext. 214, mzielinski@theneuroassociates.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in ProdromeScan Blood Test (time frame: Change monitored from baseline to 6 month time point (also assessed for change at the end of each month is this time period)). 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 22 Jul 2022.