Improving Beta-2 Adrenergic Signaling in Alzheimer's Disease

• Status: Withdrawn
• Trial end date: 2025-07-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Palo Alto Veterans Institute for Research
• Collaborators: Alzheimer's Association; Mylan Inc.
• Treatments: Adrenergic Agents; Formoterol Fumarate

Criteria

Inclusion Criteria:

• Males and females between the ages of 50-85,

• Mild-to-moderate AD (NINCDS/ADRDA criteria for probable AD will be used to establish AD diagnosis).

• MMSE 16-26.

Exclusion Criteria:

• Non-AD dementia or significant neurological disease such as Parkinson's disease, stroke, brain tumor,multiple sclerosis, seizure disorder, focal brain lesion, or head injury with loss of consciousness.

• Hypothyroidism, congestive heart failure (New York Heart Association Class III or IV), significant extrapyramidal symptoms on neurological examination, serum creatinine>1.3 mg/dl, significant arrhythmias or conduction defect abnormalities on ECG,

• Use of another beta2 adrenergic drug within the last 2 months.

• Residence in a long-term care facility.

• Evidence of any significant clinical disorder or laboratory finding that renders the person unsuitable for receiving an investigational new drug.

• Known hypersensitivity or prior exposure to formoterol.

• Active asthma or family history of asthma.