Improving Beta-2 Adrenergic Signaling in Alzheimer's Disease

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-31

Study Completion Date

2025-07-31

Brief Summary

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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).

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Detailed Description

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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

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Alzheimer's Disease Cognitive Dysfunction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Formoterol A

12 months, formoterol, 20microgram/2ml, inhaler, BID

Group Type ACTIVE_COMPARATOR

Formoterol A

Intervention Type DRUG

20mg/2mL, BID inhaler for 12 months: until progression or unacceptable toxicity develops.

Formoterol B

12 months, normal saline, 2ml, inhaler, BID

Group Type PLACEBO_COMPARATOR

Formoterol B (placebo)

Intervention Type OTHER

2mL, BID inhaler for 12 months

Interventions

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Formoterol A

20mg/2mL, BID inhaler for 12 months: until progression or unacceptable toxicity develops.

Intervention Type DRUG

Formoterol B (placebo)

2mL, BID inhaler for 12 months

Intervention Type OTHER

Other Intervention Names

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Performist

Eligibility Criteria

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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.

Minimum Eligible Age

50 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No