Trial Outcomes & Findings for Study to Assess the Efficacy of Cognitex (NCT NCT00719953)

NCT ID: NCT00719953

Last Updated: 2010-04-20

Results Overview

The computerized neuropsychological assessment software consists of seven separate tasks: symbol spotting, pattern identification, pattern recall, digit-symbol substitution, digits span forward, digits span backward and delayed pattern recall. Based on the results obtained in the single tasks, eight cognitive composite scores are calculated including focused attention, sustained attention, memory recognition \& recall, visuospatial learning, spatial short term memory, executive functions and mental flexibility.The total score range is from 0 to 100 points(0 is worse, 100 is best).

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 30 participants
• Primary outcome timeframe: Base line and 12 weeks
• Results posted on: 2010-04-20

Participant Flow

Participants were recruited through advertisements in senior citizens' homes, hospitals, and newspapers.

Participant milestones

Measure	Cognitex Treatment will consist of one capsule of Cognitex (Life Extension, USA), three times a day, with meals, delivering a total of 600 mg GPC, 100 mg PS-omega 3, 20 mg vinpocetine, 50 mg uridine-5'-monophosphate (disodium), 550 mg plant extracts (150 mg wild blueberry, 125 mg ashwagandha, 150 mg grape seed, 125 mg hops, ginger and rosemary). Duration: 15 weeks
Overall Study STARTED	30
Overall Study COMPLETED	26
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Measure	Cognitex Treatment will consist of one capsule of Cognitex (Life Extension, USA), three times a day, with meals, delivering a total of 600 mg GPC, 100 mg PS-omega 3, 20 mg vinpocetine, 50 mg uridine-5'-monophosphate (disodium), 550 mg plant extracts (150 mg wild blueberry, 125 mg ashwagandha, 150 mg grape seed, 125 mg hops, ginger and rosemary). Duration: 15 weeks
Overall Study Adverse Event	4

Baseline Characteristics

Study to Assess the Efficacy of Cognitex

Baseline characteristics by cohort

Measure	Cognitex n=30 Participants Treatment will consist of one capsule of Cognitex (Life Extension, USA), three times a day, with meals, delivering a total of 600 mg GPC, 100 mg PS-omega 3, 20 mg vinpocetine, 50 mg uridine-5'-monophosphate (disodium), 550 mg plant extracts (150 mg wild blueberry, 125 mg ashwagandha, 150 mg grape seed, 125 mg hops, ginger and rosemary). Duration: 15 weeks
Age Continuous	72.97 years STANDARD_DEVIATION 6.16 • n=5 Participants
Sex: Female, Male Female	13 Participants n=5 Participants
Sex: Female, Male Male	17 Participants n=5 Participants
Region of Enrollment Israel	30 participants n=5 Participants

PRIMARY outcome

Timeframe: Base line and 12 weeks

The computerized neuropsychological assessment software consists of seven separate tasks: symbol spotting, pattern identification, pattern recall, digit-symbol substitution, digits span forward, digits span backward and delayed pattern recall. Based on the results obtained in the single tasks, eight cognitive composite scores are calculated including focused attention, sustained attention, memory recognition & recall, visuospatial learning, spatial short term memory, executive functions and mental flexibility.The total score range is from 0 to 100 points(0 is worse, 100 is best).

Outcome measures

Measure	Cognitex n=26 Participants Treatment will consist of one capsule of Cognitex (Life Extension, USA), three times a day, with meals, delivering a total of 600 mg GPC, 100 mg PS-omega 3, 20 mg vinpocetine, 50 mg uridine-5'-monophosphate (disodium), 550 mg plant extracts (150 mg wild blueberry, 125 mg ashwagandha, 150 mg grape seed, 125 mg hops, ginger and rosemary). Duration: 15 weeks
Improvement of Cognitive Performance (Change From Baseline in Neuropsychological Computerized Test) Focused Attention	3.46 Points on a scale Standard Error 1.72
Improvement of Cognitive Performance (Change From Baseline in Neuropsychological Computerized Test) Sustained Attention	13.19 Points on a scale Standard Error 3.02
Improvement of Cognitive Performance (Change From Baseline in Neuropsychological Computerized Test) Memory - Recognition	7.92 Points on a scale Standard Error 2.13
Improvement of Cognitive Performance (Change From Baseline in Neuropsychological Computerized Test) Memory - Recall	9.19 Points on a scale Standard Error 2.44
Improvement of Cognitive Performance (Change From Baseline in Neuropsychological Computerized Test) VisuoSpatial Learning	19.84 Points on a scale Standard Error 3.78
Improvement of Cognitive Performance (Change From Baseline in Neuropsychological Computerized Test) Spatial Short Term Memory	18.88 Points on a scale Standard Error 4.62
Improvement of Cognitive Performance (Change From Baseline in Neuropsychological Computerized Test) Executive Functions	18.61 Points on a scale Standard Error 3.79
Improvement of Cognitive Performance (Change From Baseline in Neuropsychological Computerized Test) Mental Flexibility	19.65 Points on a scale Standard Error 3.80

Adverse Events

Cognitex

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Cognitex n=30 participants at risk Treatment will consist of one capsule of Cognitex (Life Extension, USA), three times a day, with meals, delivering a total of 600 mg GPC, 100 mg PS-omega 3, 20 mg vinpocetine, 50 mg uridine-5'-monophosphate (disodium), 550 mg plant extracts (150 mg wild blueberry, 125 mg ashwagandha, 150 mg grape seed, 125 mg hops, ginger and rosemary). Duration: 15 weeks
Gastrointestinal disorders Dirarrhea	6.7% 2/30 • Number of events 3
Vascular disorders Hypertension	10.0% 3/30 • Number of events 3

Additional Information

Professor N. Vaisman

Sourazky Tel-Aviv Medical Center

Phone: 972-3-6974807

Email: vaisman@tasmc.health.gov.il

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place