Improving Beta-2 Adrenergic Signaling in Alzheimer's Disease

Withdrawn before enrolling · Phase 2 · Has a placebo group

Conditions studied: Alzheimer's Disease, Cognitive Dysfunction

In brief

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).

Key facts

Study ID

NCT02500784

Run by

Palo Alto Veterans Institute for Research

People needed

0

Starts

2023-01-01

Expected to finish

2025-07-01

Last updated by the study team

2020-09-16

Who can join

Age: 50 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• VA Palo Alto Health Care System — Palo Alto, California, United States

Full record on ClinicalTrials.gov

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