Molecular Cerebral Imaging in Incipient Dementia (MCI-ID) II

NCT02317250 | Withdrawn Phase 3 DMC FDA Drug FDA Device

• 1 other identifier: 11-00815-02
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

A substantial portion of people covered by Medicare will develop Alzheimer's disease and other forms of dementia that together devastate the lives of millions of people in the United States, and cost us a total of over $200 billion every year. Getting a brain scan with a PET scanner to look for abnormal brain metabolism patterns is recognized as "reasonable and necessary" for some patients with "a recently established diagnosis of dementia" (Centers for Medicare and Medicaid Services (CMS), Decision Memo CAG-00088R), but the evidence is considered less clear for patients having less severe cognitive problems, and/or for patients getting a brain scan with a PET scanner to look for abnormal proteins in the brain (CMS Decision Memo CAG-00431N). This project employs a scientifically rigorous design (prospective, multi-centered, randomized controlled trial) to determine whether such PET scanning can help distinguish more accurately than is being done in current clinical practice those patients with early molecular changes in their brains who will benefit from Alzheimer related treatments from those patients who will not, as proven by measuring to what extent the PET scans actually lead to earlier appropriate therapy, and in fact result in improved outcomes for Medicare beneficiaries and for the health care system in which they obtain care.

Conditions

Mild Cognitive Impairment

Keywords

Alzheimer's disease; Alzheimer disease; MDC; Mild Decline in Cognition; MCI; Dementia; PET; FDG-PET; FDG; amyloid; amyloid imaging; CMS; Coverage with Evidence Development; CED; MCI-ID

Outcome Measures

Primary Outcomes (4)

• Rate of change from baseline in neuropsychological (cognitive,functional) test results

  Study participants will undergo neuropsychological testing at baseline and every six months for two years.

  baseline, 6 months, 12 months, 18 months, 24 months

• Utilization of healthcare resources

  over 2 years

• FDG-PET and amyloid imaging results, compared with working diagnoses made before and after time of imaging

  Study participants will undergo FDG-PET and amyloid imaging. Working diagnoses made before and after the imaging is performed will be compared.

  baseline and up to 2 years

• Rates of prescription of AD-specific therapies

  Comparisons between the rate of prescription for AD-specific therapies and release type (either immediate or delayed release) will be made.

  baseline, 6 months, 12 months, 18 months, 24 months

Study Arms (4)

prompt amyloid imaging, delayed FDG-PET

EXPERIMENTAL

Subject's managing physicians will be given the results of amyloid imaging scans immediately. FDG-PET results will be released two years after scanning.

Procedure: Amyloid imaging; Procedure: FDG-PET

prompt FDG-PET, delayed amyloid imaging

EXPERIMENTAL

Subject's managing physicians will be given the results of FDG-PET scans immediately. Amyloid imaging results will be released two years after scanning.

Procedure: Amyloid imaging; Procedure: FDG-PET

prompt FDG-PET, prompt amyloid imaging

EXPERIMENTAL

Both FDG-PET and amyloid imaging scan results will be made immediately available to the managing physician.

Procedure: Amyloid imaging; Procedure: FDG-PET

delayed FDG-PET, delayed amyloid imaging

ACTIVE COMPARATOR

Neither FDG-PET nor amyloid imaging scan results will be released to the managing physician for 2 years.

Procedure: Amyloid imaging; Procedure: FDG-PET

Interventions

Amyloid imaging PROCEDURE

Amyloid imaging brain scans are administered once to all arms.

delayed FDG-PET, delayed amyloid imaging; prompt FDG-PET, delayed amyloid imaging; prompt FDG-PET, prompt amyloid imaging; prompt amyloid imaging, delayed FDG-PET

FDG-PET PROCEDURE

\[F-18\] FDG-PET brain scans are administered once to all arms.

delayed FDG-PET, delayed amyloid imaging; prompt FDG-PET, delayed amyloid imaging; prompt FDG-PET, prompt amyloid imaging; prompt amyloid imaging, delayed FDG-PET

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Cognitive decline and/or personality change is present, as observable by physician and/or close contact(s) of the patient; or in the absence of this, the patient provides a clear history of decline that the patient's physician deems to be reliable.
• If history or neurologic exam reveals findings suspicious for stroke, tumor, bleed, ictal activity, or hydrocephalus, then CT/MRI and appropriate neurological or neurosurgical consultation must have been obtained.
• Standard history, physical, and laboratory screen have been performed to identify possible presence of depression, substance abuse, malnourishment, medication effects and interactions, cardiopulmonary compromise, electrolyte/calcium imbalance, anemia, hypoxemia, infection, thyroid dysfunction, renal dysfunction, hepatic dysfunction, or glucose dysregulation.
• Any positive findings revealed in 2) or 3) above have been appropriately treated, wherever possible, but cognitive/behavioral deficit persists post-therapy.

You may not qualify if:

• Subjects under age 65 will not be recruited, in order to enhance the relevance of the project by focusing on the group of Medicare beneficiaries in whom serious concerns about early signs and symptoms of senile onset dementia are most typically emerging.
• Cognitive dysfunction has impaired subject's ability to perform activities of daily living.
• Present or past history of thyroid disease.
• Claustrophobia or metal in body or other condition that would preclude PET or MRI from being acquired.
• Visual, auditory or motor deficits that would preclude accurate neuropsychological testing.
• AD-specific pharmacotherapy already initiated.

Sponsors & Collaborators

• University of California, Los Angeles: lead
• Centers for Medicare and Medicaid Services: collaborator

MeSH Terms

Conditions

Cognitive Dysfunction; Alzheimer Disease; Dementia

Condition Hierarchy (Ancestors)

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

Study Officials

• Daniel Silverman, MD, Ph.D.

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Medical and Molecular Pharmacology

Study Record Dates

• First Submitted: December 9, 2014
• First Posted: December 15, 2014
• Study Start: June 1, 2018
• Primary Completion: October 1, 2022
• Study Completion: December 1, 2022
• Last Updated: October 15, 2018

Record last verified: 2018-10