Improving Beta-2 Adrenergic Signaling in Alzheimer's Disease | NCT02500784

Studies
Improving Beta-2 Adrenergic Signaling in Alzheimer's Disease

NCT02500784

Sponsor

Palo Alto Veterans Institute for Research

Status

Withdrawn

Last Update Posted

Sep 16, 2020Actual

Enrollment

0Actual

Phase

Phase 2

Conditions

Alzheimer's Disease
Cognitive Dysfunction

Interventions

Formoterol A
Formoterol B (placebo)

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2020

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Funding ran out before study started, prior PI left institution.

Expanded Access Info

Start Date

Jan 2023Estimated

Primary Completion Date

Apr 2025Estimated

Completion Date

Jul 2025Estimated

First Submitted Date

May 19, 2015

First Submission Date that Met QC Criteria

Jul 15, 2015

First Posted Date

Jul 17, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 14, 2020

Last Update Posted Date

Sep 16, 2020Actual

Name	Class
Alzheimer's Association	OTHER
Mylan Inc.	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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).

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Formoterol A	Drug	20mg/2mL, BID inhaler for 12 months: until progression or unacceptable toxicity develops.	Formoterol A

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Amyloid accumulation	Molecular Imaging will be taken at baseline and month 16	Baseline and month 16

Other Outcomes

Not provided

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

50 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ahmad Salehi, M.D.,Ph.D.	Stanford Medical School	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
VA Palo Alto Health Care System		Palo Alto	California	94304	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

No subjects enrolled

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000544	Alzheimer Disease
D060825	Cognitive Dysfunction

Ancestor Terms

ID	Term
D003704	Dementia
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided