Leptin has been considered as a novel treatment for Alzheimer?s disease (AD), but we lack adequate evidence of a biological signal indicative of a therapeutic effect in patients with AD. Some concerns are related to side effects, along with uncertainty about dosing. We will therefore perform a pilot study in patients with AD that is sufficient in scope to assess the impact of Leptin on biomarkers selected for their relevance to the mechanism of action of Leptin and the pathobiology of AD. In addition, the study will help clarify tolerability, safety, and feasibility issues relevant for consideration of a larger subsequent trial. The trial may be used as a stepping-stone to a larger and longer multicenter trial in patients with AD or mild cognitive impairment. 45 patients with mild-moderate probable AD and plasma leptin levels of (
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| Johnston, Jane M; Hu, William T; Fardo, David W et al. (2014) Low plasma leptin in cognitively impaired ADNI subjects: gender differences and diagnostic and therapeutic potential. Curr Alzheimer Res 11:165-74 |
| Johnston, Jane M; Greco, Steven J; Hamzelou, Ashkan et al. (2011) Repositioning leptin as a therapy for Alzheimer's disease. Therapy 8:481-490 |
