Study of LM11A-31-BHS in Mild-moderate AD Patients

1. Men and women (non-childbearing potential) with a diagnosis of Alzheimer's disease according to McKhann (2011) criteria

2. Age 50-85 years (50-80 in Czech Republic)

3. MRI or CT assessment within six months before baseline, corroborating the clinical diagnosis of AD and excluding other potential causes of dementia, especially cerebrovascular lesions (see exclusion criteria, number 3)

4. CSF AD specific biomarker profile; positive, defined as CSF Aβ42 < 550 ng l-1 or an Aβ 40/42 ratio < 0.89

5. Mild to moderate stage of Alzheimer's disease according to MMSE ≥ 18 and ≤ 26

6. Absence of major depressive disease according to GDS of < 5

7. Modified Hachinski Ischemic Scale ≤ 4

8. Formal education for eight or more years

9. Previous decline in cognition for more than six months as documented in patient medical records

10. A caregiver available and living in the same household or interacting with the patient a sufficient time each week (in Czech Republic: providing personal care for the patient during at least 10 hours per week ) and available if necessary to assure administration of drug

11. Patients living at home or nursing home setting without continuous nursing care

12. General health status acceptable for a participation in a 6-month clinical trial

13. Ability to swallow capsules

14. Stable pharmacological treatment of any other chronic condition for at least one month prior to screening

15. Stable treatment with one of the acetylcholinesterase inhibitors donepezil (Aricept ®), galantamine (Razadyne®), or rivastigmine (Exelon) or the partial NMDA receptor antagonist with memantine (Namenda®) at least 3-months before baseline Visit or Combination of both treatments mentioned above

16. No regular intake of prohibited medications as noted in Section 11.8 of the protocol

17. Signed informed consent by the patient, examined and verified to be mentally capable by an independent physician, prior to the initiation of any study specific procedure. Signed consent of the caregiver (see inclusion criteria 10)

1. Failure to perform screening or baseline examinations

2. Hospitalization or change of chronic concomitant medication one month prior to screening or during screening period

3. Clinical, laboratory or neuro-imaging findings consistent with:

4. A current DSM-IV diagnosis of active major depression, schizophrenia or bipolar disorder

5. Clinically significant, advanced or unstable disease that may interfere with primary or secondary variable evaluations, and which may bias the assessment of the clinical or mental status of the patient or put the patient at special risk, such as:

6. Disability that may prevent the patient from completing all study requirements (e.g. blindness, deafness, severe language difficulty, etc.)

7. Women who are fertile and of childbearing potential

8. Chronic daily drug intake of ≥ 14 days or expected for ≥ 14 days:

9. Nootropic drugs with exception of Ginko Biloba

10. Suspected or known drug or alcohol abuse, i.e. more than approximately 60 g alcohol (approximately 1 liter of beer or 0.5 liter of wine / in Czech Republic: 20 g alcohol per day for females (500 ml of beer or 250 ml of wine) and 30g alcohol per day for males (approximately 750 ml of beer or 375 ml of wine)) per day indicated by elevated MCV significantly above normal value at screening

11. Suspected or known allergy to any components of the study treatments

12. Enrollment in another investigational study or intake of investigational drug within the previous three months

13. Any condition, which, in the opinion of the investigator, makes the patient unsuitable for inclusion

14. If patient is in any way dependent on the sponsor or the principal investigator or if the patient is accommodated in an establishment on judicial or administrative order