- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00437983
The Efficacy of Phosphatidylserine-Omega3 in Elderly With Age Associated Memory Impairment
3. januar 2010 opdateret af: Enzymotec
A Single-Center, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy of Phosphatidylserine-Omega3 in Elderly With Age Associated Memory Impairment
The primary objective of this trial is to assess the ability of an oral administration of Phosphatidylserine-Omega3 to improve attention and memory complaints in comparison to placebo in age associated memory impaired subjects.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
157
Fase
- Fase 4
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Tel Aviv, Israel, 64239
- The Tel Aviv Sourasky Medical Center, Neurology department
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
50 år til 90 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Ability to give written informed consent
- Age: 90≥ years ≥50
- Gender: male and female
- CDR ≤ 0.5
- Complaints of memory loss reflected in such everyday problems as difficulty remembering names of individuals following introduction, misplacing objects, difficulty remembering multiple items to be purchased or multiple tasks to be performed, difficulty remembering telephone numbers or zip codes, and difficulty recalling information quickly or following distraction. Onset of memory loss must be described as gradual, without sudden worsening in recent months. Complaints of memory loss to be assessed by the MAC-Q scale.
- Mini-Mental State Examination (MMSE) ≥27 for subjects with college education (BA) and ≥ 26 for all others
- Memory test performance that is at least 1 SD below the mean established for young adults on at least one neuropsychological subtest of NexAde.
- 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
- Any Neurological disorder that could produce cognitive deterioration. Such disorders include AD, 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
- Evidence of significant cerebral vascular pathology
- Head injury immediately preceding cognitive deterioration.
- Current psychiatric diagnosis according to DSM IV criteria of depression, mania, or any other major psychiatric disorder
- Current diagnosis or history of alcoholism or drug dependence.
- Evidence of depression as determined by the Geriatric Depression Scale (short version) score of 5 or more.
- 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 psychotropic drug or any other drug or supplement that may significantly affect cognitive functioning during the month prior to psychometric testing.
- Use of any experimental medication within 1 month prior to screening or as concomitant medications.
- Subject has a history of hypersensitivity or allergy to fish or fish oil or soy.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Firedobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Aktiv komparator: PS-Omega3
Phosphatidylserine-Omega3, 300mg/day 15 wk
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Phosphatidylserine-Omega3 capsules 3x100mg/day 15 wk.
Next, follow up phase, open label,1x100mg/day, 15 wk
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Placebo komparator: Placebo
Cellulose tainted with fishy odor, 3 capsules/day
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Placebo cellulose tainted with fishy odor capsules 3x100mg/day 15 wk
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Change From Baseline in Rey Auditory Verbal Learning Test
Tidsramme: baseline, 15 wk
|
A widely used, brief, easy to understand scale to evaluate verbal learning and memory.
The score is presented as the number of words correctly recalled (0 is worse, 15 is best).The total learning task score ranges from 0 to 45 words(0 is worse, 45 is best).
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baseline, 15 wk
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Blood Work
Tidsramme: baseline,15 wk
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baseline,15 wk
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Trail Making Test
Tidsramme: Baseline, 15 weeks
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Baseline, 15 weeks
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Computerized Cognitive Assessment Tool
Tidsramme: baseline, 15 weeks
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baseline, 15 weeks
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Clinical Global Impression of Change (CGI-C)Scale
Tidsramme: 7 weeks, 15 weeks
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The Clinical Global Impression of Change (CGI-C)scale is designed to record the clinician's global impression of change.
Global improvement score ranges from 1 = "Very much improved", through 4 = "No change", to 7 = "Very much worse".
Participants who experienced an improvement (scores 1, 2 or 3) in at least one of the two visits (following 7 or 15 weeks of treatment) were classified as improved over the treatment period (with the exception of participants reporting improvement following 7 weeks and deterioration at endpoint, who were NOT rated as improved)
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7 weeks, 15 weeks
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Change From Baseline in Rey Osterrieth Complex Figure Test
Tidsramme: baseline, 15 weeks
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A widely used neuropsychological tool for the evaluation of visuospatial constructional ability and visual memory.
Both the time to complete the task (copy time)and the accuracy (immediate and delayed recall) were used as measures for the analysis.
Accuracy range score is 0-36 points (0 is worse, 36 is best).
Copy time is expressed in seconds (less time to copy indicates better performance).
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baseline, 15 weeks
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Studieleder: Amos Korczyn, MD, Sourasky Medical Center
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. april 2007
Primær færdiggørelse (Faktiske)
1. juni 2008
Studieafslutning (Faktiske)
1. september 2008
Datoer for studieregistrering
Først indsendt
20. februar 2007
Først indsendt, der opfyldte QC-kriterier
20. februar 2007
Først opslået (Skøn)
21. februar 2007
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
5. januar 2010
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
3. januar 2010
Sidst verificeret
1. januar 2010
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- Memory_PS 001
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med Age Associated Memory Impairment
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Dart NeuroScience, LLCAfsluttetAge-Associated Memory Impairment (AAMI)Forenede Stater
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