Alzheimer‘s disease
Conditions
Interventions
probiotic group:The probiotic group received both the approved AD treatment and one sachet of Probio-M8 powder per day (2 g per sachet
3×10*10 CFU/sachet/day),
Control group:An approved enteral nutrition with the same appearance, taste and color as probio-m8, 2g/ day, once a day (at the same time every day), taken orally half an hour after meal for 6 months.
Sponsors
Beijing Tiantan Hospital, Capital Medical University
Eligibility
Sex/Gender
All
Age
50 Years to 85 Years
Inclusion criteria
Inclusion criteria: 1.Meet the National Institute of Aging–Alzheimers Association (NIA-AA) core clinical criteria for probable AD. 2.Have a global CDR score from 0.5 to 2 and a CDR Memory Box score of 0.5 or greater at Screening and Baseline. 3.Male or female subjects aged =50 and =85 years, at the time of informed consent. 4.MMSE score greater than or equal to 15 at Screening and Baseline and less than or equal to 25 at Screening and Baseline. 5.If receiving an approved AD treatment, such as acetylcholinesterase inhibitors (AChEIs), or memantine, or both for AD, must be on a stable dose for at least 12 weeks prior to Baseline. Treatment-na?ve subjects for AD can be entered into the study. Unless otherwise stated, subjects must have been on stable doses of all other (ie, non-AD-related) permitted concomitant medications for at least 12 weeks prior to Baseline. 6.Have an identified study partner (defined as a person able to support the subject for the duration of the study and who spends at least 8 hours per week with the subject). The study partner must provide separate written informed consent. In addition, this person must be willing and able to provide follow-up information on the subject throughout the course of the study. This person must, in the opinion of the investigator, spend sufficient time with the subject on a regular basis such that the study partner can reliably fulfill the study requirements. A permanent study partner need not be living in the same residence with the subject. For such a study partner not residing with the subject, the investigator has to be satisfied that the subject can contact the study partner readily during the times when the study partner is not with the subject. If in doubt about whether a subject's care arrangements are suitable for inclusion, the investigator should discuss this with the medical monitor. Study partners need to participate in person for visits where clinical assessment of CDR (global and CDR-SB), CDRNPICog-12CBIADAS-Cog. 7.Provide written informed consent of subjects and study partners.
Exclusion criteria
Exclusion criteria: (1)Females who are breastfeeding or pregnant at Screening or Baseline. (2)Any neurological condition that may be contributing to cognitive impairment above and beyond that caused by the subjects AD. (3)History of transient ischemic attacks (TIA), stroke, or seizures within 12 months of Screening. (4)Before or during the study,according to the fifth edition of the diagnostic and Statistical Manual of mental disorders (DSM-5), any psychiatric diagnosis or symptoms,(eg, hallucinations, major depression, or delusions) that could interfere with study procedures in the subject. (5)HAMD-17 >24 or HAMA =21 at Screening or Baseline. (6)Contraindications to MRI scanning, including cardiac pacemaker/defibrillator, ferromagnetic metal implants (eg, in skull and cardiac devices other than those approved as safe for use in MRI scanners). (7)Evidence of other clinically significant lesions on brain MRI at Screening that could indicate a dementia diagnosis other than AD. (8)Other significant pathological findings on brain MRI at Screening. (9)Any other clinically significant abnormalities in physical examination, vital signs, laboratory tests, or ECG at Screening or Baseline which in the opinion of the investigator require further investigation or treatment or which may interfere with study procedures or safety. (10)Subjects with malignant neoplasms within 6 months of Screening. (11)Intake of probiotics-based products 1 month before the trial started. (12)Severe visual or hearing impairment that would prevent the subject from performing psychometric tests accurately. (13) Known or suspected history of drug or alcohol abuse before Screening or a positive urine drug test at Screening. (14) Have a history of inflammatory bowel disease, intestinal obstruction, intestinal perforation, intestinal bleeding, celiac disease, irritable bowel syndrome or eosinophilia, esophagitis, eosinophilic gastroenteritis and other similar diseases. (15) Participated in any other investigational medication or device study in the 4 weeks of the medication before randomization
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cognition; | — |
Secondary
| Measure | Time frame |
|---|---|
| neuropsychiatric symptoms;activity of daily living;Inflammation and metabolic markers;Nutritional status;cerebral blood flow;Safety; | — |
Countries
China
Contacts
Public ContactJun Xu
Beijing Tiantan Hospital, Capital Medical University
Outcome results
None listed