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

NCT02211560 | Terminated

• 1 other identifier: Vayacog_002
• Study Type: interventional
• Target: 97
• Locations: 2 countries
• Sites: 15

Brief Summary

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

Conditions

Mild Cognitive Impairment

Outcome Measures

Primary Outcomes (1)

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

  baseline, 3, 6,12 months

Secondary Outcomes (6)

• 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

Other Outcomes (1)

• Safety of phosphatidylserine versus placebo treatment

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

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Identical looking cellulose capsules

Other: Placebo

Phosphatidylserine

EXPERIMENTAL

Phosphatidylserine-omega-3, DHA enriched

Other: Phosphatidylserine

Interventions

Phosphatidylserine OTHER

Phosphatidylserine

Placebo OTHER

Placebo

Eligibility Criteria

• Age: 65 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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:
• 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

You may not qualify if:

• 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)
• 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.

Sponsors & Collaborators

• Enzymotec: lead

Study Sites (15)

Pharmacology Research Institute

Encino, California, 91316, United States

Location

Pharmacology Research Institute

Los Alamitos, California, 90720, United States

Location

Pharmacology Research Institute

Newport Beach, California, United States

Location

New West Physicians, PC

Golden, Colorado, 80401, United States

Location

Miami Jewish Health Systems

Miami, Florida, 33137, United States

Location

APG Research LLC

Orlando, Florida, 32803, United States

Location

University of South Florida

Tampa, Florida, 33613, United States

Location

Great Lakes Clinical Trials

Chicago, Illinois, 60640, United States

Location

Memory Enhancement Center of America

Eatontown, New Jersey, 07724,, United States

Location

Princeton Medical Institute

Princeton, New Jersey, 08540, United States

Location

Integrative Clinical Trials, LLC

Brooklyn, New York, 11229, United States

Location

The Medical Research Network

New York, New York, 10128,, United States

Location

Lehigh Center for Clinical Research

Allentown, Pennsylvania, 18104, United States

Location

Rambam medical center, Israel

Haifa, Israel

Location

Ichilov medical center

Tel Aviv, Israel

Location

MeSH Terms

Conditions

Cognitive Dysfunction

Interventions

Phosphatidylserines

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Glycerophospholipids; Phosphatidic Acids; Glycerophosphates; Phospholipids; Membrane Lipids; Lipids

Study Officials

• Yehudit Aharon, MD

  Rambam medical center, Israel

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 6, 2014
• First Posted: August 7, 2014
• Study Start: September 1, 2014
• Primary Completion: December 25, 2017
• Study Completion: December 25, 2017
• Last Updated: February 5, 2018

Record last verified: 2018-02

Locations

US (13); IL (2)