NCT02500784

Improving Beta-2 Adrenergic Signaling in Alzheimer's Disease

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Palo Alto Veterans Institute for Research · Academic / Other
• Sex: All
• Age: 50 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to test the effects of long-term therapeutic doses of formoterol, on a) cerebrospinal fluid (CSF) tau levels, and Amyloid Beta protein 40/42 levels in the CSF, and b) cognitive function in people with mild to moderate Alzheimer' Disease (AD).

Detailed description

The purpose of this study is to test the effects of long-term therapeutic doses of formoterol, on a) cerebrospinal fluid CSF tau levels, and A-beta amyloid protein 40/42 levels, and b) cognitive function: NE-ergic neurons undergo significant degeneration in AD. This system plays a significant role in cognition. Recent studies have indicated that increasing NE levels in the brain would significantly improve microglia migration and clearance of A-beta amyloid protein 40/42 levels in mouse models of AD. The investigators plan to test whether long- term daily treatment with inhaled formoterol solution would improve the structure and function of hippocampal neurons in AD. Study Design: Randomization and initiation of experimental treatment: All participants will be given formoterol daily for 52 weeks. The active regimen will be initiated as (20 micro gram, BID). The dose will be decreased if there is evidence of side effects, including cardiac or respiratory alteration changes, gastro-intestinal disturbances or neurological issues.

Conditions

• Alzheimer's Disease
• Cognitive Dysfunction

Interventions

Type	Name	Description
DRUG	Formoterol A	20mg/2mL, BID inhaler for 12 months: until progression or unacceptable toxicity develops.
OTHER	Formoterol B (placebo)	2mL, BID inhaler for 12 months

Timeline

• Start date: 2023-01-01
• Primary completion: 2025-04-01
• Completion: 2025-07-01
• First posted: 2015-07-17
• Last updated: 2020-09-16

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study