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Completed

NCT Number: NCT00719953

Study to Assess the Efficacy of Cognitex

A Single-Center, Open Label Study to Assess the Efficacy of Cognitex in Elderly Subjects with Memory Impairment

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Key information

Age range

60 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Suorasky Medical Center

Tel Aviv, Israel

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Ability to give written informed consent.
  • Age: 90≥ years ≥60.
  • Gender: male and female.
  • Memory test performance within or below the mean established for adults in the computerized cognitive tool, with a maximum of four neuropsychological subtests scored 1.5 SD above the mean.
  • Language: Subjects must be able to read, write and speak Hebrew.
  • Ability to perform tests and interviews.

Exclusion criteria

  • Evidence of delirium, confusion, or other disturbances of consciousness.
  • Evidence of dementia.
  • Any Neurological disorder that could produce cognitive deterioration. Such disorders include Parkinson's disease, stroke, intracranial hemorrhage, local brain lesions including tumors and normal pressure hydrocephalus.
  • History of any infective or inflammatory brain disease including those of viral, fungal, or syphilitic etiologies.
  • Head injury immediately preceding cognitive deterioration.
  • Evidence of depression as determined by a the Geriatric Depression Scale (short version) score of 5 or more.
  • Current diagnosis or history of alcoholism or drug dependence.
  • Any medical disorder that could produce cognitive deterioration including renal, respiratory, cardiac, and hepatic disease, diabetes mellitus, endocrine, metabolic or hematological disturbances unless well controlled, and malignancy not in remission for more than two years
  • Use of anti-clotting or antiplatelet medications or supplements for less than two years.
  • History of clotting or platelet disorder unless well controlled.
  • Use of any supplement that may significantly affect cognitive functioning during the month prior to study initiation.
  • Use of any experimental medication within 1 month prior to screening or as concomitant medications.
  • History of hypersensitivity or allergy to soy or fish.

Treatment and study plan

Cognitex

Dietary Supplement

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

Primary outcomes

  1. Improvement of Cognitive Performance (Change From Baseline in Neuropsychological Computerized Test)

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Tel-Aviv Sourasky Medical Center

Other Gov

Collaborators

  • Enzymotec

Registry information

Official study title

A Single-Center, Open-label Study to Assess the Efficacy of Cognitex in Elderly Subjects With Memory Impairment

Acronym: Cognitex001

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Jul 22, 2008
Registry last updated
Apr 20, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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