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

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

Study Overview

• Status: Terminated
• Conditions: Mild Cognitive Impairment
• Intervention / Treatment: Other: Placebo; Other: Phosphatidylserine

• Study Type: Interventional
• Enrollment (Actual): 97
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Haifa, Israel
    • Rambam Medical Center, Israel
  • Tel-Aviv, Israel
    • Ichilov Medical Center
• United States
  • California
    • Encino, California, United States, 91316
      • Pharmacology Research Institute
    • Los Alamitos, California, United States, 90720
      • Pharmacology Research Institute
    • Newport Beach, California, United States
      • Pharmacology Research Institute
  • Colorado
    • Golden, Colorado, United States, 80401
      • New West Physicians, PC
  • Florida
    • Miami, Florida, United States, 33137
      • Miami Jewish Health Systems
    • Orlando, Florida, United States, 32803
      • APG Research LLC
    • Tampa, Florida, United States, 33613
      • University of South Florida
  • Illinois
    • Chicago, Illinois, United States, 60640
      • Great Lakes Clinical Trials
  • New Jersey
    • Eatontown, New Jersey, United States, 07724,
      • Memory Enhancement Center of America
    • Princeton, New Jersey, United States, 08540
      • Princeton Medical Institute
  • New York
    • Brooklyn, New York, United States, 11229
      • Integrative Clinical Trials, LLC
    • New York, New York, United States, 10128,
      • The Medical Research Network
  • Pennsylvania
    • Allentown, Pennsylvania, United States, 18104
      • Lehigh Center for Clinical Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years to 85 years (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Age greater than or equal to 65 and less than or equal to 85 years.
2. Formal education greater than or equal to 10 years.

3. 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.

4. Adequate vision, hearing, and literacy ability to allow for neuropsychological testing.
5. Able and willing to perform all study procedures.
6. Ability to provide written consent signed by the subject

Exclusion Criteria:

1. Any significant neurological condition or disorder (e.g., seizure disorder, epilepsy, brain tumors, stroke, etc.) that could cause cognitive deterioration other than suspected MCI.
2. 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.
3. Clinically significant abnormal serum TSH and/or B-12 and/or folic acid levels below the normal range.
4. History of any infective or inflammatory brain disease including viral, fungal or syphilitic etiologies.
5. Head trauma or injury immediately preceding cognitive deterioration, unless over 2 years have passed since full cognitive and functional recovery.
6. Depression at screening as assessed by Geriatric Depression Scale-short version (score ≥5)
7. Current suicidality at screening by Columbia Suicidality Severity Rating Scale.
8. Dementia by DSM-IV criteria.
9. 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.
10. Concomitant use of any medications approved for the symptomatic treatment of dementia due to AD (e.g., NMDA, acetyl choline esterase inhibitors)
11. 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).
12. 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).
13. Use within 4 weeks prior to the study entry of medical foods indicated for cognitive or memory impairment [e.g. Axona, Cerefolin, CerefolinNAC, Souvenaid].
14. Concomitant use of any supplements containing ingredients with nootropic or vasodilator properties (e.g., Ginkgo Biloba, Vinpocetine, Piracetam, high energy supplements).
15. Use of an investigational drug within the last 30 days.
16. Allergic reaction or sensitivity to marine products (fish/seafood) and/or soy.
17. 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Identical looking cellulose capsules	Other: Placebo
Experimental: Phosphatidylserine; Phosphatidylserine-omega-3, DHA enriched	Other: Phosphatidylserine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Difference in change in the Selective Reminding Test (SRT) between the study groups.	baseline, 3, 6,12 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Mini Mental State Examination (MMSE)	baseline, 12 and 24 months
Computerized Neurological battery test (NBT)	baseline, 6, 12 and 24 months
Transition rate to dementia according to DSM-4 criteria	baseline, 3, 6, 12, 18 and 24 months
Mini Sleep Questionnaire (MSQ)	baseline, 12 and 24 months
Hamilton Anxiety Rating Scale (HAM-A).	baseline, 12 and 24 months
Selective Reminding Test (SRT)	18 and 24 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety of phosphatidylserine versus placebo treatment	Clinical laboratory safety data will be collected at baseline and 24 months. Vital signs will be measured at baseline, 12 and 24 months. Adverse events (including changes to concomitant medications) will be documented at all study visits (i.e baseline, 3, 6, 12, 18 and 24 months).	baseline, 3, 6, 12, 18 and 24 months

Collaborators and Investigators

• Sponsor: Enzymotec
• Investigators: Principal Investigator: Yehudit Aharon, MD, Rambam Medical Center, Israel

Study record dates

Study Major Dates

• Study Start: September 1, 2014
• Primary Completion (Actual): December 25, 2017
• Study Completion (Actual): December 25, 2017

Study Registration Dates

• First Submitted: August 6, 2014
• First Submitted That Met QC Criteria: August 6, 2014
• First Posted (Estimate): August 7, 2014

Study Record Updates

• Last Update Posted (Actual): February 5, 2018
• Last Update Submitted That Met QC Criteria: February 1, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Neurocognitive Disorders; Cognition Disorders; Cognitive Dysfunction
• Other Study ID Numbers: Vayacog_002