Table 1.

Key inclusion and exclusion criteria.

Key inclusion criteria

Adult competent persons.

Diagnosed with Alzheimer’s disease (AD) with an MMSE score of 18–21.

The diagnosis should be entirely based on clinical findings, while diagnosis by MMSE with a score >22 should be diagnosed by spinal puncture.

Age >50 years and <80 years.

Caucasians.

Key exclusion criteria

Diabetes mellitus.

Clinically significant liver or renal impairment (serum alanine amino transferase >2 times upper reference or creatinine-clearance <60 ml/min, assessed on Cockcroft-Gault normogram).

Clinically significant anemia.

Current or former presence of one of the following diseases with clinical relevance: another central nervous system illness other than diagnosed depression treated with SSRI or SSRI similar drugs; liver disease; kidney disease; endocrinological disease other than well- controlled hypothyroidism.

Current or history of chronic or acute pancreatitis.

Patients treated with tricyclic antidepressants or neuroleptics.

Significant abnormalities in the brain detected by magnetic resonance imaging.

MMSE, Mini-Mental State Examination; SSRI, selective serotonin re-uptake inhibitors.