Implications of Amyloid Pathology

NCT00900770 | Unknown

• 3 other identifiers: IA01582P50AG005134-2683812P50AG005134
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine whether asymptomatic older individuals with high amyloid burden will subsequently manifest cognitive impairment and eventually progress to clinical Alzheimer's Disease (AD).

Conditions

Alzheimer's Disease

Keywords

dementia; mild cognitive impairment; beta amyloid

Outcome Measures

Primary Outcomes (1)

• Pittsburgh Compound B (PiB) and F-18 fluorodeoxyglucose (FDG) PET Scan

  at 1 month

Secondary Outcomes (2)

• Cognitive and functional assessments

  Baseline and annually for 5 years

• Lumbar Puncture (optional)

  Baseline

Study Arms (2)

PIB+ NC

PIB positive, cognitively normal individuals with foci of elevated PIB retention in cortical regions typically affected in AD

PIB- NC

PIB negative, cognitively normal individuals without amyloid deposition

Eligibility Criteria

• Age: 60 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Longitudinal cohort of the Massachusetts Alzheimer's Disease Research Center and community volunteers

You may qualify if:

• Age range from 60 to 90 years
• Clinical Dementia Rating (CDR) Score of 0
• Mini Mental State Exam of 27-30
• A study partner who can answer questions pertaining to daily functioning
• Perform within 1.5 standard deviation of age and education matched norms on screening tests of attention and executive function, language, visuospatial perception and episodic memory
• Stable medications for at least 30 days
• Fluent in English
• Modified Hachinski Score of \<4
• Geriatric Depression Scale Score \<10

You may not qualify if:

• Diagnosis of MCI or dementia
• Individuals with contraindications to MRI (i.e., implanted metal including pacemakers, cerebral spinal fluid shunts, aneurysm clips, artificial heart valves, ear implants or metal/foreign objects in the eyes and those with a history of claustrophobia)
• Unstable medications or on medications with CNS effects including cholinesterase inhibitors, memantine, and antidepressants
• Major psychiatric disorders such as schizophrenia, schizoaffective disorder, major affective disorder, or treatment with ECT (mild depression that is well treated with stable dose of SSRI antidepressants will be allowed)
• Multiple sclerosis or other autoimmune disorders
• Huntington's disease
• Head injury, post-traumatic dementia or seizures
• Metabolic encephalopathy, CNS infection, hydrocephalus
• Cardiovascular disease, stroke, congestive heart failure
• Substance abuse within the past 2 years
• Active cancer
• Active hematological, renal, pulmonary, endocrine or hepatic disorders

Sponsors & Collaborators

• National Institute on Aging (NIA): lead

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

RECRUITING

Related Publications (4)

• Dickerson BC, Bakkour A, Salat DH, Feczko E, Pacheco J, Greve DN, Grodstein F, Wright CI, Blacker D, Rosas HD, Sperling RA, Atri A, Growdon JH, Hyman BT, Morris JC, Fischl B, Buckner RL. The cortical signature of Alzheimer's disease: regionally specific cortical thinning relates to symptom severity in very mild to mild AD dementia and is detectable in asymptomatic amyloid-positive individuals. Cereb Cortex. 2009 Mar;19(3):497-510. doi: 10.1093/cercor/bhn113. Epub 2008 Jul 16.

  PMID: 18632739 BACKGROUND

• Aizenstein HJ, Nebes RD, Saxton JA, Price JC, Mathis CA, Tsopelas ND, Ziolko SK, James JA, Snitz BE, Houck PR, Bi W, Cohen AD, Lopresti BJ, DeKosky ST, Halligan EM, Klunk WE. Frequent amyloid deposition without significant cognitive impairment among the elderly. Arch Neurol. 2008 Nov;65(11):1509-17. doi: 10.1001/archneur.65.11.1509.

  PMID: 19001171 BACKGROUND

• Jack CR Jr, Lowe VJ, Senjem ML, Weigand SD, Kemp BJ, Shiung MM, Knopman DS, Boeve BF, Klunk WE, Mathis CA, Petersen RC. 11C PiB and structural MRI provide complementary information in imaging of Alzheimer's disease and amnestic mild cognitive impairment. Brain. 2008 Mar;131(Pt 3):665-80. doi: 10.1093/brain/awm336. Epub 2008 Feb 7.

  PMID: 18263627 BACKGROUND

• Mintun MA, Larossa GN, Sheline YI, Dence CS, Lee SY, Mach RH, Klunk WE, Mathis CA, DeKosky ST, Morris JC. [11C]PIB in a nondemented population: potential antecedent marker of Alzheimer disease. Neurology. 2006 Aug 8;67(3):446-52. doi: 10.1212/01.wnl.0000228230.26044.a4.

  PMID: 16894106 BACKGROUND

MeSH Terms

Conditions

Alzheimer Disease; Dementia; Cognitive Dysfunction; Plaque, Amyloid

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Cognition Disorders; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Reisa Sperling, MD

  Director of Clinical Research, Memory Disorders Unit, Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: NIH

Study Record Dates

• First Submitted: May 11, 2009
• First Posted: May 13, 2009
• Study Start: November 1, 2008
• Primary Completion: March 1, 2014
• Study Completion: March 1, 2014
• Last Updated: December 29, 2009

Record last verified: 2009-12

Locations

US (1)