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

NCT ID: NCT02211560

Last Updated: 2018-02-05

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 97 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-09-30
• Study Completion Date: 2017-12-25

Brief Summary

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

Conditions

Mild Cognitive Impairment

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: QUADRUPLE

Study Groups

Placebo

Identical looking cellulose capsules

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Phosphatidylserine

Phosphatidylserine-omega-3, DHA enriched

Group Type: EXPERIMENTAL

Phosphatidylserine

Intervention Type: OTHER

Interventions

Phosphatidylserine

Intervention Type: OTHER

Placebo

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 65 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Enzymotec

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yehudit Aharon, MD

Role: PRINCIPAL_INVESTIGATOR

Rambam medical center, Israel

Locations

Pharmacology Research Institute

Encino, California, United States

Pharmacology Research Institute

Los Alamitos, California, United States

Pharmacology Research Institute

Newport Beach, California, United States

New West Physicians, PC

Golden, Colorado, United States

Miami Jewish Health Systems

Miami, Florida, United States

APG Research LLC

Orlando, Florida, United States

University of South Florida

Tampa, Florida, United States

Great Lakes Clinical Trials

Chicago, Illinois, United States

Memory Enhancement Center of America

Eatontown, New Jersey, United States

Princeton Medical Institute

Princeton, New Jersey, United States

Integrative Clinical Trials, LLC

Brooklyn, New York, United States

The Medical Research Network

New York, New York, United States

Lehigh Center for Clinical Research

Allentown, Pennsylvania, United States

Rambam medical center, Israel

Haifa, , Israel

Ichilov medical center

Tel Aviv, , Israel

Countries

United States; Israel

Other Identifiers

Vayacog_002

Identifier Type: -

Identifier Source: org_study_id