Clinical trial NCT02211560: Investigating a Phosphatidylserine Based Dietary Approach for the Management of Mild Cognitive Impairment
Official title: A, Multi-center, Double-blind, Randomized, Placebo-controlled Study for the Efficacy of Phosphatidylserine in Mild Cognitive Impairment (MCI)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Mild Cognitive Impairment
Lead sponsor: Enzymotec
Sponsor class: INDUSTRY
First posted: 2014-08-07
Enrollment: 97
Sex: ALL
Minimum age (years): 65
Maximum age (years): 85
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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


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

Primary outcomes:
measure: Difference in change in the Selective Reminding Test (SRT) between the study groups.
timeFrame: baseline, 3, 6,12 months
Secondary outcomes:
measure: Mini Mental State Examination (MMSE)
timeFrame: baseline, 12 and 24 months
measure: Computerized Neurological battery test (NBT)
timeFrame: baseline, 6, 12 and 24 months
measure: Transition rate to dementia according to DSM-4 criteria
timeFrame: baseline, 3, 6, 12, 18 and 24 months
measure: Mini Sleep Questionnaire (MSQ)
timeFrame: baseline, 12 and 24 months
measure: Hamilton Anxiety Rating Scale (HAM-A).
timeFrame: baseline, 12 and 24 months
measure: Selective Reminding Test (SRT)
timeFrame: 18 and 24 months
Other outcomes:
measure: Safety of phosphatidylserine versus placebo treatment
timeFrame: baseline, 3, 6, 12, 18 and 24 months
Locations:
city: Encino
country: United States
facility: Pharmacology Research Institute
state: California
city: Los Alamitos
country: United States
facility: Pharmacology Research Institute
state: California
city: Newport Beach
country: United States
facility: Pharmacology Research Institute
state: California
city: Golden
country: United States
facility: New West Physicians, PC
state: Colorado
city: Miami
country: United States
facility: Miami Jewish Health Systems
state: Florida
city: Orlando
country: United States
facility: APG Research LLC
state: Florida
city: Tampa
country: United States
facility: University of South Florida
state: Florida
city: Chicago
country: United States
facility: Great Lakes Clinical Trials
state: Illinois
city: Eatontown
country: United States
facility: Memory Enhancement Center of America
state: New Jersey
city: Princeton
country: United States
facility: Princeton Medical Institute
state: New Jersey
city: Brooklyn
country: United States
facility: Integrative Clinical Trials, LLC
state: New York
city: New York
country: United States
facility: The Medical Research Network
state: New York
city: Allentown
country: United States
facility: Lehigh Center for Clinical Research
state: Pennsylvania
city: Haifa
country: Israel
facility: Rambam medical center, Israel
city: Tel-Aviv
country: Israel
facility: Ichilov medical center
Study officials:
affiliation: Rambam medical center, Israel
name: Yehudit Aharon, MD
role: PRINCIPAL_INVESTIGATOR
References: