NL-OMON49237已完成不适用
Providing quantitative biological measures to facilitate the discovery and development of new treatments for social and cognitive deficits in Alzheimer*s disease and schizophrenia. - PRISM
niversitair Medisch Centrum Utrecht0 个研究点目标入组 138 人开始时间: 待定最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 138
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 至 64（—）
入选标准
- •1. Provision of signed and dated informed consent form (ICF) from patient and consent from study partner (if this person contributes data to the study) prior to any study-specific procedures being performed.
- •2. Half of each patient group (AD and SZ) must have a score <=<10 on a subset of items from the WHODAS-2 (social withdrawal) scale, and half must have a score of ><=11. In this way patients are characterised as lower or higher in social withdrawal, respectively.
- •3. Not socially withdrawn due to external circumstances (e.g. lack of access to transport, e.g. rural location) or comorbid medical disorder or disability (e.g., hearing loss, lack of mobility, facial disfigurement).
- •4. Patient and study partner must be able to read, write, and speak the language in which psychometric tests are provided, with acceptable visual and auditory acuity (corrected if necessary with MRI compatible materials e.g. plastic lens for sight correction).
- •5. Patients must be considered reliable and have a level of understanding sufficient to perform all tests and examinations required by the protocol, and be willing to perform all study procedures.
- •6. Unless otherwise stated CNS medications to treat cognitive impairment, due to AD or symptoms of SZ and other stable CNS conditions requiring such medication, is permitted provided the patient has been maintained on a stable dose regimen for at least 8 weeks before start of the study, and they are expected to continue this treatment in a stable manner during the current study.
- •7. Patients must have an adequate hearing of the 1000Hz frequency with no greater loss than 40dB at screening using an automated audiometric assessment.
- •8. Patient is right-handed or ambidextrous.;Inclusion Criteria * AD participants
- •1. Men and women aged 50 to 80 years (inclusive).
- •2. Probable AD, meeting the National Institute on Aging (NIA) and the Alzheimer*s Association (AA) (NIA-AA) criteria for probable AD, and
- •3. MMSE score of 20 to 26, inclusive. ;Inclusion Criteria * SZ participants
- •1. Patients are male or female, 18-45 years of age (inclusive) with an established diagnosis of schizophrenia according to medical history.
- •2. If the patient uses any antipsychotic, anticholinergic or antidepressant (see below) medication, dosage needs to be stable for at least 8 weeks prior to the study start.
- •3. Based on the screening MINI, a DSM-4 diagnosis of SZ with at least one confirmed psychotic episode but not longer than 15 years of disease duration (since first date of established SZ clinical diagnosis).;Inclusion Criteria * HC participants
- •1. Men and women, aged 18-45 inclusive (of similar age distribution and gender proportion to SZ group) or 50-80 inclusive (of similar age distribution and gender proportion to AD group)
- •2. Provision of signed and dated informed consent form (ICF) from participant prior to any study-specific procedures being performed.
- •3. Participant must be able to read, write, and speak the language in which psychometric tests are provided, with acceptable visual and auditory acuity (corrected if necessary with MRI compatible materials e.g. plastic lens for sight correction).
- •4. Participants must be considered reliable and be willing to perform all study procedures.
- •5. Participants must have an adequate hearing of the 1000Hz frequency with no greater loss than 40dB at screening using an automated audiometric assessment
- •6. Younger and older h
排除标准
- •Exclusion criteria (both SZ and AD populations):;1. Significant neurological disease affecting the CNS, other than AD and SZ, (e.g. other dementias, serious infection of the brain, Parkinson*s disease, epilepsy) as documented in the patient*s medical file which in the judgement of the investigator may affect the patient's ability to complete the study assessments.
- •2. Patients with a current Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-4) diagnosis of Major Depressive Disorder (MDD) as assessed by the MINI, and with a QIDS-SR16 score of * 16
- •3. Patients with or any other current primary psychiatric diagnosis requiring intervention other than AD (as per DSM-4) or SZ (as per DSM-4) using the MINI that in the judgement of the investigator may affect the patient's ability to complete the study assessments.
- •4. Current serious or unstable clinically important systemic illness (e.g. hepatic, renal, gastroenterologic, respiratory, cardiovascular, endocrinologic, immunologic, hematologic, or ocular disorders) that in the judgment of the investigator may affect the patient's ability to complete the study assessments.
- •5. Has history of chronic alcohol or drug abuse or dependence within the previous 3 years.;Medication
- •1. Participated in any investigational study to treat either AD or SZ symptoms or has taken an investigational drug within 90 days (or 5 times the half-life of the investigational drug, whichever is longer). In addition, if they have participated in two or more studies with an experimental drug within 5 months prior to screening.
- •2. Is currently requiring antidepressant or anxiolytic medication, unless treatment is stable as indicated in the inclusion criteria.
- •3. In the investigator*s judgement is medically non-compliant in the management of their disease.
- •4. Has within 6 weeks prior to the first assessment visit been prescribed a medication that may affect the CNS that in the judgment of the investigator may interfere with the patient's ability to complete the study assessments.;Procedural
- •Has any contraindications for MRI studies, including claustrophobia, the presence of metal (ferromagnetic) implants, pregnancy, or cardiac pacemaker that is not compatible with MRI scanning.;Exclusion Criteria * AD participants:
- •1. Multiple strokes based on history and/or previous imaging results
- •2. A score of 4 or greater on the global Parkinsonism item of the ESRS-A (only relevant to those patients currently taking an antipsychotic medication).;Exclusion Criteria * SZ participants:
- •1. A score of 22 or more on the sum of the 7 PANSS positive symptom factor items. The score of the items of P1 (delusions), P3 (hallucinatory behaviour), P6 (suspiciousness) and G9 (unusual thought content) meet the following requirements:
- •1.1. No more than 2 of the above items have a score of 4.
- •1.2. All of the above items score less than 5.
- •2. In the clinician*s judgment, patients who, for any reason, are considered to be a danger to themselves.
- •3. A score of 4 or greater on the global Parkinsonism item of the ESRS-A.;Exclusion Criteria * HC participants
- •1. Current, or history of, Axis-I psychiatric disorder as determined by the MINI at the Screening Visit.
- •2. Participant scores >5 on the QIDS (indicative of mild or more severe depression)
- •3. Is currently, or has ever, required antidepressant or anxiolytic medication, including benzodiazepines (with the excep
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