Diagnostic Phase: Not determined Treatment Phase: Adults (male and female)with suspected mild cognitive impairment (MCI)
Conditions
Interventions
iRemember device
Placebo device
Sponsors
Clinical Creative Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Age: Japanese between 65 and 80 years old (at the time of obtaining consent) (2) Gender: male and female 3) Those who can commute to the medical institution where the study will be conducted 4) Composite score B less than 90 both times in the two Cogstate Brief Battery (CBB) tests conducted in the DiagnosticPhase. (5) Those who have the ability to operate a computer mouse and keyboard. (6) Those who can participate in the study for about 15 weeks. 7) Those who have normal to almost normal vision and hearing. (vii) Those with normal to almost normal vision and hearing, and those who can use corrective lenses, hearing aids, etc. if necessary. (viii) A person who is willing to participate twice a week for the trial of the research equipment.
Exclusion criteria
Exclusion criteria: (1) Those who have participated in a clinical study using the investigational drug within 6 months prior to study enrollment. 2) Those with a history of psychotic disorder, currently active depression, bipolar disorder, adjustment disorder, somatoform disorder, anxiety disorder OCD, or PTSD. (following Axis-1 disorders listed in ICD-10) Those who drink a lot of alcohol on a daily basis (iii) Alcoholism or drug addiction as defined in ICD-10 within the past 5 years (in remission for more than 1 year and/or less than 3 years) or severe sleep deprivation. 4) History of clinically defined neurological/psychiatric disorders including but not limited to: epilepsy, dementia, clinical stroke (hemiplegia, paraplegia), substance abuse, Parkinson's or other extrapyramidal disorders, major head injury, multiple sclerosis, or personal history of previous neurosurgery or head injury resulting in loss of consciousness, use of drugs intended to improve cognition (cholinesterase inhibitors)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in learning/working memory score from baseline (V1) to 15 weeks after the start of training with the research instrument | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in psychomotor function/Attention score from baseline (V1) to 15 weeks after the start of training with the research instrument Change in each task (Detection, Identification, One-Card Learning, and One-Back) score from baseline (V1) to 15 weeks after the start of training with the research instrument Change in QOL from baseline (V1) to 15 weeks after the start of training with the research device, calculated using EQ-5D-5L. | — |
Countries
Japan
Contacts
Public ContactKazuhiro Ohno
Clinical Creative Co., Ltd. Pharmaceutical Development Division
Outcome results
None listed