Improving Beta-2 Adrenergic Signaling in Alzheimer's Disease

NCT02500784 | Withdrawn Phase 2 FDA Drug

• 1 other identifier: ASJ0015
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Alzheimer's Disease; Cognitive Dysfunction

Outcome Measures

Primary Outcomes (2)

• Cognition Evaluation

  Participants will be administered the CANTAB every month for 16 months

  1 Month

• Brain-derived neurotrophic factor (BDNF) Evaluation

  Samples of Plasma and Cerebral Spinal Fluid Biomarkers will be taken at baseline and month 16

  Baseline and month 16

Secondary Outcomes (1)

• Amyloid accumulation

  Baseline and month 16

Study Arms (2)

Formoterol A

ACTIVE COMPARATOR

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

Drug: Formoterol A

Formoterol B

PLACEBO COMPARATOR

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

Other: Formoterol B (placebo)

Interventions

Formoterol A DRUG

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

Also known as: Performist

Formoterol A

Formoterol B (placebo) OTHER

2mL, BID inhaler for 12 months

Formoterol B

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Palo Alto Veterans Institute for Research: lead
• Alzheimer's Association: collaborator
• Mylan Inc.: collaborator

Study Sites (1)

VA Palo Alto Health Care System

Palo Alto, California, 94304, United States

Location

MeSH Terms

Conditions

Alzheimer Disease; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Cognition Disorders

Study Officials

• Ahmad Salehi, M.D.,Ph.D.

  Stanford Medical School

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: May 19, 2015
• First Posted: July 17, 2015
• Study Start: January 1, 2023
• Primary Completion: April 1, 2025
• Study Completion: July 1, 2025
• Last Updated: September 16, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)