- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT00526942
Behavioral and Physiological Effects of Visual Training
Computer-Based Cognitive Training in Normal Healthy Aging: Pilot Study of Behavioral and Physiological Effects of Visual Sweeps Training Exercise, 2-Arm Model
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
Virtually all adults will suffer a decline in their cognitive capacities to some degree. Typically, cognitive decline is characterized by a slow, progressive decline in abilities (frequently in memory, attention, inhibition and speed of processing) relative to younger adults, commonly called normal aging, age-associated memory impairment, age-consistent memory impairment, benign senescent forgetfulness, late-life forgetfulness, ageing-associated cognitive decline, and the preferred term, age-related cognitive decline (ARCD) As virtually all adults experience a reduction in their cognitive abilities with age, ARCD has generally been considered to be a normal, inevitable, and irreversible part of aging; and the extremely severe forms of pathological cognitive decline (e.g., Alzheimer's disease, AD) have dominated therapeutic research in this area. However, ARCD represents an important cause of quality of life decline in almost every older adult, as the impact of forgetfulness and mental slowing increasingly change the abilities of individuals to successfully manage their day-to-day activities. Therapeutic approaches targeting the specific problems of ARCD in normal aging (as opposed to the pathological problems of AD) would unto themselves represent important clinical advances.
This trial investigates the effects of a computer-based visual training exercise built on the principles of positive brain plasticity and designed for use by healthy mature individuals. The program is specifically designed to improve the fidelity of sensory representations in early visual cortex.
Tipo di studio
Iscrizione (Anticipato)
Fase
- Fase 2
- Fase 1
Contatti e Sedi
Luoghi di studio
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California
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San Francisco Bay Area, California, Stati Uniti, 94104
- Reclutamento
- Posit Science Corporation
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Contatto:
- Cate Stasio, BA
- Numero di telefono: 3546 4153943100
- Email: cate.stasio@positscience.com
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Contatto:
- Daniel Tinker, BS
- Numero di telefono: 3541 415-394-3100
- Email: daniel.tinker@positscience.com
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Investigatore principale:
- Joseph L Hardy, PhD
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Sub-investigatore:
- Daniel Tinker, BS
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- Age 60 or older at the time of consent.
- Mini-Mental Status Examination (MMSE) score of 26 or higher.
- Adequate visual capacity adequate to read.
- Adequate hearing capacity.
- Willing and able to commit to study time requirements.
Exclusion Criteria:
- Self-report of current diagnosis or history of major neurological illness.
- Self-report of current diagnosis or history of psychiatric illness. c. History of psychiatric hospitalization in the past twenty years.
- History of a stroke, transient ischemic attack (TIA) or traumatic brain injury within the past year; or lifetime history of stroke, TIA, or traumatic brain injury that has left residual expressive or receptive language problems. - Fibromyalgia or symptoms of severe tremor.
- Self-report of current substance abuse, including alcoholism.
- Current useof medications with substantial CNS effects. Inappropriate behaviors during screening or baseline visits.
- Inability to perform behavioral evaluations.
- Participant is not capable of giving informed consent or unable to comprehend and/or follow instructions.
- Participant is enrolled in a concurrent clinical study that could affect the outcome of this study.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Nessun intervento: I
No contact control (NCC)
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|
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Sperimentale: II
Computerized, SAAGE-designed, visual memory-based cognitive training
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Training sessions take 40 minutes per day, five days per week for a total goal of 15, 40-minute sessions.
Altri nomi:
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
|---|---|
|
Improvement in visual memory assessment after training or no-contact period.
Lasso di tempo: 6-8 weeks
|
6-8 weeks
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Misure di risultato secondarie
Misura del risultato |
Lasso di tempo |
|---|---|
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Improvement on at least 1 of the Computerized Visual Attention, Speed and Memory Tests conducted.
Lasso di tempo: 6-8 weeks
|
6-8 weeks
|
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Improvement on the computerized cognitive assessments.
Lasso di tempo: 6-8 weeks
|
6-8 weeks
|
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Improvement on exercise-based assessments.
Lasso di tempo: 6-8 weeks
|
6-8 weeks
|
Collaboratori e investigatori
Sponsor
Collaboratori
Investigatori
- Investigatore principale: Joseph L Hardy, PhD, Posit Science Corporation
Pubblicazioni e link utili
Pubblicazioni generali
- Bischkopf J, Busse A, Angermeyer MC. Mild cognitive impairment--a review of prevalence, incidence and outcome according to current approaches. Acta Psychiatr Scand. 2002 Dec;106(6):403-14. doi: 10.1034/j.1600-0447.2002.01417.x.
- Fillit HM, Butler RN, O'Connell AW, Albert MS, Birren JE, Cotman CW, Greenough WT, Gold PE, Kramer AF, Kuller LH, Perls TT, Sahagan BG, Tully T. Achieving and maintaining cognitive vitality with aging. Mayo Clin Proc. 2002 Jul;77(7):681-96. doi: 10.4065/77.7.681.
- Ahissar E, Nagarajan S, Ahissar M, Protopapas A, Mahncke H, Merzenich MM. Speech comprehension is correlated with temporal response patterns recorded from auditory cortex. Proc Natl Acad Sci U S A. 2001 Nov 6;98(23):13367-72. doi: 10.1073/pnas.201400998.
- Park HL, O'Connell JE, Thomson RG. A systematic review of cognitive decline in the general elderly population. Int J Geriatr Psychiatry. 2003 Dec;18(12):1121-34. doi: 10.1002/gps.1023.
- Scarmeas N, Stern Y. Cognitive reserve: implications for diagnosis and prevention of Alzheimer's disease. Curr Neurol Neurosci Rep. 2004 Sep;4(5):374-80. doi: 10.1007/s11910-004-0084-7.
Collegamenti utili
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento dello studio (Anticipato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Altri numeri di identificazione dello studio
- RES-203-2007
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .