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

• Sponsor: Enzymotec (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT02211560
• Collaborator: (none)
• Enrollment: 97
• Locations: 15
• Arms: 2
• Duration (Months): 39.8
• Patients Per Site: 6.5
• Patients Per Site Per Month: 0.2

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Mild Cognitive Impairment	Other: Phosphatidylserine; Other: Placebo	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 97 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Other
• Official Title: A, Multi-center, Double-blind, Randomized, Placebo-controlled Study for the Efficacy of Phosphatidylserine in Mild Cognitive Impairment (MCI)
• Study Start Date: Sep 1, 2014
• Actual Primary Completion Date: Dec 25, 2017
• Actual Study Completion Date: Dec 25, 2017

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Difference in change in the Selective Reminding Test (SRT) between the study groups. [baseline, 3, 6,12 months]

Secondary Outcome Measures

1. Mini Mental State Examination (MMSE) [baseline, 12 and 24 months]

2. Computerized Neurological battery test (NBT) [baseline, 6, 12 and 24 months]

3. Transition rate to dementia according to DSM-4 criteria [baseline, 3, 6, 12, 18 and 24 months]

4. Mini Sleep Questionnaire (MSQ) [baseline, 12 and 24 months]

5. Hamilton Anxiety Rating Scale (HAM-A). [baseline, 12 and 24 months]

6. Selective Reminding Test (SRT) [18 and 24 months]

Other Outcome Measures

1. Safety of phosphatidylserine versus placebo treatment [baseline, 3, 6, 12, 18 and 24 months]

   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).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 65 Years to 85 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

1. Adequate vision, hearing, and literacy ability to allow for neuropsychological testing.

2. Able and willing to perform all study procedures.

3. 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pharmacology Research Institute	Encino	California	United States	91316
2	Pharmacology Research Institute	Los Alamitos	California	United States	90720
3	Pharmacology Research Institute	Newport Beach	California	United States
4	New West Physicians, PC	Golden	Colorado	United States	80401
5	Miami Jewish Health Systems	Miami	Florida	United States	33137
6	APG Research LLC	Orlando	Florida	United States	32803
7	University of South Florida	Tampa	Florida	United States	33613
8	Great Lakes Clinical Trials	Chicago	Illinois	United States	60640
9	Memory Enhancement Center of America	Eatontown	New Jersey	United States	07724,
10	Princeton Medical Institute	Princeton	New Jersey	United States	08540
11	Integrative Clinical Trials, LLC	Brooklyn	New York	United States	11229
12	The Medical Research Network	New York	New York	United States	10128,
13	Lehigh Center for Clinical Research	Allentown	Pennsylvania	United States	18104
14	Rambam medical center, Israel	Haifa		Israel
15	Ichilov medical center	Tel-Aviv		Israel

Sponsors and Collaborators

• Enzymotec

Investigators

• Principal Investigator: Yehudit Aharon, MD, Rambam medical center, Israel

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Enzymotec
• ClinicalTrials.gov Identifier: NCT02211560
• Other Study ID Numbers: Vayacog_002
• First Posted: Aug 7, 2014
• Last Update Posted: Feb 5, 2018
• Last Verified: Feb 1, 2018

• Additional relevant MeSH terms: Cognitive Dysfunction

Study Results

No Results Posted as of Feb 5, 2018