- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT00437983
The Efficacy of Phosphatidylserine-Omega3 in Elderly With Age Associated Memory Impairment
3. januar 2010 oppdatert av: 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.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Faktiske)
157
Fase
- Fase 4
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
-
Tel Aviv, Israel, 64239
- The Tel Aviv Sourasky Medical Center, Neurology department
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
50 år til 90 år (Voksen, Eldre voksen)
Tar imot friske frivillige
Ja
Kjønn som er kvalifisert for studier
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Firemannsrom
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Aktiv komparator: PS-Omega3
Phosphatidylserine-Omega3, 300mg/day 15 wk
|
Phosphatidylserine-Omega3 capsules 3x100mg/day 15 wk.
Next, follow up phase, open label,1x100mg/day, 15 wk
|
|
Placebo komparator: Placebo
Cellulose tainted with fishy odor, 3 capsules/day
|
Placebo cellulose tainted with fishy odor capsules 3x100mg/day 15 wk
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
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).
|
baseline, 15 wk
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Blood Work
Tidsramme: baseline,15 wk
|
baseline,15 wk
|
|
|
Trail Making Test
Tidsramme: Baseline, 15 weeks
|
Baseline, 15 weeks
|
|
|
Computerized Cognitive Assessment Tool
Tidsramme: baseline, 15 weeks
|
baseline, 15 weeks
|
|
|
Clinical Global Impression of Change (CGI-C)Scale
Tidsramme: 7 weeks, 15 weeks
|
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)
|
7 weeks, 15 weeks
|
|
Change From Baseline in Rey Osterrieth Complex Figure Test
Tidsramme: baseline, 15 weeks
|
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).
|
baseline, 15 weeks
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Studieleder: Amos Korczyn, MD, Sourasky Medical Center
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. april 2007
Primær fullføring (Faktiske)
1. juni 2008
Studiet fullført (Faktiske)
1. september 2008
Datoer for studieregistrering
Først innsendt
20. februar 2007
Først innsendt som oppfylte QC-kriteriene
20. februar 2007
Først lagt ut (Anslag)
21. februar 2007
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
5. januar 2010
Siste oppdatering sendt inn som oppfylte QC-kriteriene
3. januar 2010
Sist bekreftet
1. januar 2010
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- Memory_PS 001
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .