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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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.

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 groups in NCT05041088
Study groupRoleWhat they receive
Experimental Group (ALL participants)ExperimentalThis 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.

  1. 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)
  1. 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)

  2. 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)

  3. 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)

  4. 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)

  5. 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)

  6. 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)

  7. 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)

  8. 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.

  1. First posted10 Sep 2021
  2. Study start20 Jun 2023 (estimated)
  3. Primary completion20 Sep 2023 (estimated)
  4. Study completion20 Nov 2023 (estimated)

Resources

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)
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

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.

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