. 2017 Dec 2;9:92. doi: 10.1186/s13195-017-0321-3

Table 5.

Inclusion and exclusion criteria of the BioAdaptAD study

Inclusion criteria	Exclusion criteria
Patients must meet all of the following inclusion criteria to participate in the study: • Patient is male or female and between ≥ 55 and ≤ 85 years of age on the day of signing the consent form. • If female, patient is not of reproductive potential (2 years postmenopausal or surgically sterile). • Patient has a subjective memory concern as reported by subject, study partner, or clinician. • Patient has an abnormal memory function documented by scoring below the • Education-adjusted ranges on the Auditory Verbal Learning Test total learning or delayed recall percentage ≥ −1 SD. • Patient has a global Clinical Dementia Rating of 0 or 0.5. • In the opinion of the investigator, the patient is in stable medical condition and willing and able to perform study procedures. • Patient has at least 6 years of education or work history sufficient, in the investigator’s opinion, to exclude intellectual disability.	Patients will be ineligible for participation in this study if they meet any of the following exclusion criteria: • Patient has a history or current evidence of a neurological disorder that, in the opinion of the primary investigator, may contribute to the subject’s cognitive impairment, including but not limited to: – Large-vessel stroke – Epilepsy – Parkinson’s disease – Progressive supranuclear palsy – Huntington’s disease – Amyotrophic lateral sclerosis – Multiple sclerosis – Central nervous system infection – Significant head trauma with loss of consciousness – Normal-pressure hydrocephalus • Patient has a history of large-vessel stroke or evidence of a large-vessel infarction or other focal lesions seen on baseline magnetic resonance imaging (MRI) scan that may contribute to the cause of the memory impairment in the opinion of the investigator. • Patient has received an examination over the past year involving > 10 mSv of ionizing radiation • Patient has a history within 6 months prior to screening visit or current evidence of a psychotic disorder or untreated major depressive disorder. • Patient has a history of malignancy ≤ 5 years prior to signing informed consent, except for patients who have undergone potentially curative therapy with no evidence of recurrence for 1 year and who are deemed at low risk for recurrence by her/his treating physician. • Patient has a history or current evidence of any potentially known clinically significant condition therapy, laboratory abnormality, or other circumstance that, in the opinion of the investigator, might confound the results of the study or interfere with the patient’s participation for the full duration of the study, such that it is not in the best interest of the patient to participate. • Patient currently uses specific psychoactive medications (e.g., neuroleptics, chronic anxiolytics, tricyclic antidepressants, antiepileptics, anticholinergics). Stable-dose trazodone, mirtazapine, or low-dose benzodiazepines prescribed for mild insomnia are allowed. • Patient currently uses antithrombotics, with the exception of acetylsalicylic acid (exclusionary for lumbar puncture). • Patient has a history of alcohol or substance abuse or dependence within the past 2 years (based on criteria of the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition). • Patient is currently participating or has participated in a study with an investigational compound or neuropsychological measures within 30 days of signing informed consent. • Subject has any magnetizable metal prostheses, implants, or foreign objects that could pose a hazard during MRI scanning.

Inclusion criteria

Exclusion criteria

Patients must meet all of the following inclusion criteria to participate in the study:
• Patient is male or female and between ≥ 55 and ≤ 85 years of age on the day of signing the consent form.
• If female, patient is not of reproductive potential (2 years postmenopausal or surgically sterile).
• Patient has a subjective memory concern as reported by subject, study partner, or clinician.
• Patient has an abnormal memory function documented by scoring below the
• Education-adjusted ranges on the Auditory Verbal Learning Test total learning or delayed recall percentage ≥ −1 SD.
• Patient has a global Clinical Dementia Rating of 0 or 0.5.
• In the opinion of the investigator, the patient is in stable medical condition and willing and able to perform study procedures.
• Patient has at least 6 years of education or work history sufficient, in the investigator’s opinion, to exclude intellectual disability.

Patients will be ineligible for participation in this study if they meet any of the following exclusion criteria:
• Patient has a history or current evidence of a neurological disorder that, in the opinion of the primary investigator, may contribute to the subject’s cognitive impairment, including but not limited to:
– Large-vessel stroke
– Epilepsy
– Parkinson’s disease
– Progressive supranuclear palsy
– Huntington’s disease
– Amyotrophic lateral sclerosis
– Multiple sclerosis
– Central nervous system infection
– Significant head trauma with loss of consciousness
– Normal-pressure hydrocephalus
• Patient has a history of large-vessel stroke or evidence of a large-vessel infarction or other focal lesions seen on baseline magnetic resonance imaging (MRI) scan that may contribute to the cause of the memory impairment in the opinion of the investigator.
• Patient has received an examination over the past year involving > 10 mSv of ionizing radiation
• Patient has a history within 6 months prior to screening visit or current evidence of a psychotic disorder or untreated major depressive disorder.
• Patient has a history of malignancy ≤ 5 years prior to signing informed consent, except for patients who have undergone potentially curative therapy with no evidence of recurrence for 1 year and who are deemed at low risk for recurrence by her/his treating physician.
• Patient has a history or current evidence of any potentially known clinically significant condition therapy, laboratory abnormality, or other circumstance that, in the opinion of the investigator, might confound the results of the study or interfere with the patient’s participation for the full duration of the study, such that it is not in the best interest of the patient to participate.
• Patient currently uses specific psychoactive medications (e.g., neuroleptics, chronic anxiolytics, tricyclic antidepressants, antiepileptics, anticholinergics). Stable-dose trazodone, mirtazapine, or low-dose benzodiazepines prescribed for mild insomnia are allowed.
• Patient currently uses antithrombotics, with the exception of acetylsalicylic acid (exclusionary for lumbar puncture).
• Patient has a history of alcohol or substance abuse or dependence within the past 2 years (based on criteria of the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition).
• Patient is currently participating or has participated in a study with an investigational compound or neuropsychological measures within 30 days of signing informed consent.
• Subject has any magnetizable metal prostheses, implants, or foreign objects that could pose a hazard during MRI scanning.