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Mild Cognitive ImpairmentNCT02211560

Investigating a Phosphatidylserine Based Dietary Approach for the Management of Mild Cognitive Impairment

A study testing Phosphatidylserine in people with Mild Cognitive Impairment, run by Enzymotec at 15 sites in 2 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

The primary objective is to evaluate the efficacy and safety of phosphatidylserine (PS) on cognitive abilities in MCI Read more about this study

Who is it for?
Ages 65 to 85 years
Conditions the study is for
Mild Cognitive Impairment
What is being tested?
Phosphatidylserine
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
97 participants
Where
15 sitesin 2 countries
Study dates
Sep 2014to 25 Dec 2017
Phase
Interventional
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 65 to 85 years
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • Age greater than or equal to 65 and less than or equal to 85 years.
  • Formal education greater than or equal to 10 years.
  • Male or female with a diagnosis of Mild Cognitive Impairment (MCI) 3. Male or female with a diagnosis of Mild Cognitive Impairment (MCI) as defined by Peterson, according to The following:
  • 3.1 Clinical Dementia Rating Scale total score (CDR) ≤0.5, and score of each one of the six categories ("box scores") ≤ 1. 3.2 Mini Mental State Exam > 24 3.3 Verbal Paired-Associated Learning test score according to the following ages: Ages 65-70 less than or equal to 18 Ages 71-85 less than or equal to 17
  • Eligibility of subjects aged between 70 and 71 (i.e., 70.1) will be evaluated according to 71-85 age group score.
  • Adequate vision, hearing, and literacy ability to allow for neuropsychological testing.
  • Able and willing to perform all study procedures.
  • Ability to provide written consent signed by the subject

Who cannot join

  • Any significant neurological condition or disorder (e.g., seizure disorder, epilepsy, brain tumors, stroke, etc.) that could cause cognitive deterioration other than suspected MCI.
  • Any medical condition or disorder that could produce cognitive deterioration (i.e., renal, respiratory, cardiac, and hepatic disease, diabetes mellitus, endocrine, metabolic or hematological disturbances) unless well controlled for at least 3 months.
  • Clinically significant abnormal serum TSH and/or B-12 and/or folic acid levels below the normal range.
  • History of any infective or inflammatory brain disease including viral, fungal or syphilitic etiologies.
  • Head trauma or injury immediately preceding cognitive deterioration, unless over 2 years have passed since full cognitive and functional recovery.
  • Depression at screening as assessed by Geriatric Depression Scale-short version (score ≥5)
Show all 17Show fewer
  • Current suicidality at screening by Columbia Suicidality Severity Rating Scale.
  • Dementia by DSM-IV criteria.
  • Concomitant use of medications with potent psychotropic properties (e.g. antipsychotics, ADHD treatments, lithium carbonate, anti-epileptic drugs such as Gabapentin). Sedating antihistamines are allowed if administered last dose is administered at least 12 hours before cognitive testing. Usage of prescription or nonprescription antidepressant agents, lipid lowering medications, and anti-hypertensive medications with a stable dosage for more than 2 months prior study entry is permitted.
  • Concomitant use of any medications approved for the symptomatic treatment of dementia due to AD (e.g., NMDA, acetyl choline esterase inhibitors)
  • Use within 3 weeks prior to study entry of any medications with any anti-cholinergic effect (e.g. Atropine, Scopolamine, Tolterodine, Hyoscyamine, Biperiden, Benzatropine, Trihexyphenidyl, Oxybutynin).
  • Use within 4 weeks prior to the study entry of dietary supplements containing DHA, EPA, Phosphatidylserine, Phosphatidylcholine (e.g. Krill oil, Lecithin), or alpha-glycerphosphocholine (GPC).
  • Use within 4 weeks prior to the study entry of medical foods indicated for cognitive or memory impairment [e.g. Axona, Cerefolin, CerefolinNAC, Souvenaid].
  • Concomitant use of any supplements containing ingredients with nootropic or vasodilator properties (e.g., Ginkgo Biloba, Vinpocetine, Piracetam, high energy supplements).
  • Use of an investigational drug within the last 30 days.
  • Allergic reaction or sensitivity to marine products (fish/seafood) and/or soy.
  • Any known condition which in the opinion of the investigator may be possibly causing cognitive impairment other than AD (mania, alcohol or substance abuse, mental retardation, bipolar disorder, panic disorder, obsessive compulsive disorder, post-traumatic stress disorder, psychotic disorder, major psychiatric disorder preceding dementia onset or affecting brain function, major surgery ) and/or limits the successful trial completion

Trial locations and contacts

15 sites in 2 countries.

15 sites in 2 countries

United States13 sites

  • Lehigh Center for Clinical Research

    Allentown, Pennsylvania, 18104

  • Integrative Clinical Trials, LLC

    Brooklyn, New York, 11229

  • Great Lakes Clinical Trials

    Chicago, Illinois, 60640

  • Memory Enhancement Center of America

    Eatontown, New Jersey, 07724,

  • Pharmacology Research Institute

    Encino, California, 91316

  • New West Physicians, PC

    Golden, Colorado, 80401

  • Pharmacology Research Institute

    Los Alamitos, California, 90720

  • Miami Jewish Health Systems

    Miami, Florida, 33137

  • The Medical Research Network

    New York, New York, 10128,

  • Pharmacology Research Institute

    Newport Beach, California

  • APG Research LLC

    Orlando, Florida, 32803

  • Princeton Medical Institute

    Princeton, New Jersey, 08540

  • University of South Florida

    Tampa, Florida, 33613

Other trials in United States

Israel2 sites

  • Rambam medical center, Israel

    Haifa

  • Ichilov medical center

    Tel Aviv

Other trials in Israel

About this study

Official title: A, Multi-center, Double-blind, Randomized, Placebo-controlled Study for the Efficacy of Phosphatidylserine in Mild Cognitive Impairment (MCI)

The primary objective is to evaluate the efficacy and safety of phosphatidylserine (PS) on cognitive abilities in MCI

Being tested
Phosphatidylserine, Placebo
Medical subject headings
Cognitive Dysfunction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PhosphatidylserineOther

  • PlaceboOther

Study groups in NCT02211560
Study groupRoleWhat they receive
PlaceboPlacebo comparatorIdentical looking cellulose capsules
Receives: Other: Placebo
PhosphatidylserineExperimentalPhosphatidylserine-omega-3, DHA enriched
Receives: Other: Phosphatidylserine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Difference in change in the Selective Reminding Test (SRT) between the study groups.

    Measured: baseline, 3, 6,12 months

Secondary outcomes (6)

  1. Mini Mental State Examination (MMSE)

    Measured: baseline, 12 and 24 months

  2. Computerized Neurological battery test (NBT)

    Measured: baseline, 6, 12 and 24 months

  3. Transition rate to dementia according to DSM-4 criteria

    Measured: baseline, 3, 6, 12, 18 and 24 months

  4. Mini Sleep Questionnaire (MSQ)

    Measured: baseline, 12 and 24 months

  5. Hamilton Anxiety Rating Scale (HAM-A).

    Measured: baseline, 12 and 24 months

  6. Selective Reminding Test (SRT)

    Measured: 18 and 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Aug 2014 (estimated)
  2. Study startSep 2014
  3. Primary completion25 Dec 2017
  4. Study completion25 Dec 2017

Why it stopped: Due to difficulties in patient recruitment

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 N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
97 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02211560
Sponsor's protocol ID
Vayacog_002
Status last verified
Feb 2018
First submitted
6 Aug 2014
Last updated
5 Feb 2018
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A study testing Phosphatidylserine in people with Mild Cognitive Impairment, run by Enzymotec at 15 sites in 2 countries.

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 8 inclusion and 17 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: stopped early, as of the sponsor's last update on 5 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 sites in United States, Israel. 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. Some participants in this study may receive a placebo. 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 was stopped early (reason given: Due to difficulties in patient recruitment). Results are not available in the source record.

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?

Difference in change in the Selective Reminding Test (SRT) between the study groups. (time frame: baseline, 3, 6,12 months). 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 NCT02211560.

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 5 Feb 2018.

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