Changes in Cognition in HCV Patients After Virus Eradication With Direct Antiviral Agents
Changes in Cognition in HCV Patients After Virus Eradication With Direct Antiviral Agents. Relationship With Clinical and Sociodemographic Variables
Studieoversikt
Status
Forhold
Detaljert beskrivelse
The aim of this study is to investigate the effect that the eradication of the HCV has on cognition, quality of life and psychopathology. At the same time, investigators intend to study the association between cognitive changes and some clinical variables.
The sample consists of 80 subjects (40 HCV patients and 40 HCV patients coinfected with the Human Immunodeficiency Virus, HIV). Exclusion criteria: Cirrhosis, presence of minimal hepatic encephalopathy or active drug consumption.
A neuropsychological assessment is made before the treatment with direct antiviral agents to evaluate memory, executive functions, processing speed, anxiety, depression and quality of life. Additionally, the following clinical variables are collected: Viral charge, immunosuppression (measured with T Cells CD4 (CD4), CD4 nadir and T Cells CD8 (CD8)) and fibrosis level, HCV genotype and plasma biomarkers: Brain-Derived Neurotrophic Factor (BDNF), Interleukine 6 (IL6), Tumor Necrosis Factor (TNF-a),Glial fibrillary acidic protein (GFAP), Soluble CD14 (SCD14), Neuro-specific enolase (NSE).
The second neuropsychological assessment and clinical data collection is carried out after treatment, concretely 6 months after HCV is undetectable in plasma.
Studietype
Registrering (Faktiske)
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
Inclusion Criteria:
- Patients over 18 years old with indication to receive antiviral treatment
- Diagnosis of chronic infection by hepatitis C virus in the fibrous phase F3 or F4 that have not presented any clinical decompensation of their liver disease, with or without HIV co-infection
Exclusion Criteria:
- Active alcohol consumption> 40g daily or history of chronic alcoholism
- Active consumption of other toxics (heroin, cocaine, cannabis)
- Patients with minimum hepatic encephalopathy
- Background of cerebral neurological disease, chronic renal insufficiency and / or psychiatric illnesses assessed according to the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria, which can affect cognitive functions.
- Active use of psychotropics or benzodiazepines
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Memory tests
Tidsramme: baseline, change at 6 months after treatment
|
Rey Auditory Verbal Learning Test (RVLT, Spreen & Strauss 1998) assesses verbal learning, recall and recognition memory; Wechsler Adults Intelligence Scale III backward digits subtest (WAIS, Wechsler 1997) assesses working memory.
All direct scores have been transformed into T-scores (mean=50; SD=10), which allows to obtain a single memory component.
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baseline, change at 6 months after treatment
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|
Attention tests
Tidsramme: baseline, change at 6 months after treatment
|
Continous Performance Test (CPT, Conners 2000) assesses sustained attention, inattentiveness and impulsivity; WAIS forward digits subtest (WAIS III, Wechsler 1997) assesses attention.
All direct scores have been transformed into T-scores (mean=50; SD=10), which allows to obtain a single attention component.
|
baseline, change at 6 months after treatment
|
|
Executive function tests
Tidsramme: baseline, change at 6 months after treatment
|
Stroop Test (Stroop, 1935) assesses flexibility and inhibition of automatic responses; Trail Making Test (TMTA-B Reitan, 1993) assesses visual tracking and flexibility, phonetic and semantic fluency tests (Lezak, 1995) assess verbal fluency; Tower of London (Culbertson & Zillmer, 2005) assesses visual reasoning and planification.
All direct scores have been transformed into T-scores (mean=50; SD=10), which allows to obtain a single executive function component.
|
baseline, change at 6 months after treatment
|
|
Speed processing test
Tidsramme: baseline, change at 6 months after treatment
|
Digit symbol test (WAIS III, Wechsler 1997) assesses visuomotor speed.
The direct scores have been transformed into T-scores (mean=50; SD=10).
|
baseline, change at 6 months after treatment
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Hospital Anxiety and Depression Scale (HADS)
Tidsramme: baseline, change at 6 months after treatment
|
It is a self-registering scale of 14 items: 7 items evaluating anxiety and 7 items evaluating depression (Zigmond & Snaith, 1983). Scoring range: 0-21 for each subscale. Scores >10 in each subscale imply a significant anxious/depressive symptomatology. |
baseline, change at 6 months after treatment
|
|
36-Item Short Form Health Survey (SF-36 )
Tidsramme: baseline, change at 6 months after treatment
|
It is a self-registered scale for the assessment of quality of life ( Alonso y cols.
, 1995).
It consists on 8 dimensions: Physical functioning, limitations for physical issues, corporal pain, social functioning, mental health, limitations for emotional issues, vitality and general perception of the own health.
For each dimension, the scoring range goes from 0 to 100, where higher values represent better outcome (better quality of life/less limitations/better functioning).
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baseline, change at 6 months after treatment
|
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Fibroscan
Tidsramme: Baseline, change at 6 months after treatment
|
Degree of fibrosis: Speed of propagation of elastic waves measured with fibroscan.
|
Baseline, change at 6 months after treatment
|
|
HCV RNA
Tidsramme: Baseline, change at 3 months after treatment, change at 6 months after treatment.
|
Viral load quantity measured by plasma HCV RNA is collected in HIV co-infected patients
|
Baseline, change at 3 months after treatment, change at 6 months after treatment.
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Immunosuppression state
Tidsramme: Baseline
|
The next cells were analyzed in blood, in HIV co-infected patients : CD4, %CD4, nadir CD4, CD8, % CD8, CD4/CD8 ratio.
|
Baseline
|
Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Blood Biomarkers measures
Tidsramme: 1 day pretreatment and change at 6 months post treatment
|
The next blood biomarkers were collected: Brain-derived neurotrophic factor (BDNF); Interleukine 6 (Il-6); Tumor Necrosis Factor (TNF-a ); Glial fibrillary acidic protein (GFAP); Soluble SCD 14 (sCD14) ; Neuro-specific enolase (NSE).
|
1 day pretreatment and change at 6 months post treatment
|
Samarbeidspartnere og etterforskere
Sponsor
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- CIR2015/042
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