Donepezil and Brain Activity Patterns in Those at Risk For Alzheimer's Disease

NCT00408525 | Completed Phase 1

• 1 other identifier: 040686
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is to examine patterns of brain activity in people who are at risk for memory problems (e.g., Alzheimer's disease or dementia)before and after the medication donepezil. Although genetic testing will be done, the results will not be shared with study participants. Once the genetic testing is completed subjects may continue to the second phase of the study. During this time they will be asked to take the medication donepezil (which is approved by the FDA for the treatment of Alzheimer's disease). Donepezil is not FDA approved for healthy volunteers and is therefore considered investigational in this study.

Conditions

Alzheimer's Disease

Keywords

memory loss; memory problems; alzheimer's; forgetfulness; forgetting

Outcome Measures

Primary Outcomes (1)

• Changes in brain activation patterns as measured in an fMRI.

  8 weeks

Study Arms (1)

1

EXPERIMENTAL

Donepezil

Drug: donepezil

Interventions

donepezil DRUG

donepezil 5 mg tablets, total dose per day 10 mg for 6 week duration of study. Taken once per day.

Also known as: Aricept

1

Eligibility Criteria

• Age: 40 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects may report experiencing subjective memory dysfunction, however they must be found by clinical evaluation to have no memory dysfunction
• Neuropsychological test battery in the normal range
• Ages 40-85

You may not qualify if:

• Dementia (Mini-Mental State Exam less than 25/30)
• Left-handedness
• Current medication that could influence cognition
• Medical, psychiatric, and neurologic conditions, including cerebrovascular disease or uncontrolled hypertension
• Claustrophobia
• Surgical clips or implants
• Pacemakers or other implanted electronic devices
• History of sheet metal work

Sponsors & Collaborators

• Vanderbilt University: lead

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37212, United States

Location

Related Publications (9)

• Bookheimer SY, Strojwas MH, Cohen MS, Saunders AM, Pericak-Vance MA, Mazziotta JC, Small GW. Patterns of brain activation in people at risk for Alzheimer's disease. N Engl J Med. 2000 Aug 17;343(7):450-6. doi: 10.1056/NEJM200008173430701.

  PMID: 10944562 BACKGROUND

• Morris JC. Is Alzheimer's disease inevitable with age?: Lessons from clinicopathologic studies of healthy aging and very mild alzheimer's disease. J Clin Invest. 1999 Nov;104(9):1171-3. doi: 10.1172/JCI8560. No abstract available.

  PMID: 10545515 BACKGROUND

• Small GW, Mazziotta JC, Collins MT, Baxter LR, Phelps ME, Mandelkern MA, Kaplan A, La Rue A, Adamson CF, Chang L, et al. Apolipoprotein E type 4 allele and cerebral glucose metabolism in relatives at risk for familial Alzheimer disease. JAMA. 1995 Mar 22-29;273(12):942-7.

  PMID: 7884953 BACKGROUND

• Reiman EM, Caselli RJ, Yun LS, Chen K, Bandy D, Minoshima S, Thibodeau SN, Osborne D. Preclinical evidence of Alzheimer's disease in persons homozygous for the epsilon 4 allele for apolipoprotein E. N Engl J Med. 1996 Mar 21;334(12):752-8. doi: 10.1056/NEJM199603213341202.

  PMID: 8592548 BACKGROUND

• Small GW, Ercoli LM, Silverman DH, Huang SC, Komo S, Bookheimer SY, Lavretsky H, Miller K, Siddarth P, Rasgon NL, Mazziotta JC, Saxena S, Wu HM, Mega MS, Cummings JL, Saunders AM, Pericak-Vance MA, Roses AD, Barrio JR, Phelps ME. Cerebral metabolic and cognitive decline in persons at genetic risk for Alzheimer's disease. Proc Natl Acad Sci U S A. 2000 May 23;97(11):6037-42. doi: 10.1073/pnas.090106797.

  PMID: 10811879 BACKGROUND

• Burggren AC, Small GW, Sabb FW, Bookheimer SY. Specificity of brain activation patterns in people at genetic risk for Alzheimer disease. Am J Geriatr Psychiatry. 2002 Jan-Feb;10(1):44-51.

  PMID: 11790634 BACKGROUND

• Smith CD, Andersen AH, Kryscio RJ, Schmitt FA, Kindy MS, Blonder LX, Avison MJ. Women at risk for AD show increased parietal activation during a fluency task. Neurology. 2002 Apr 23;58(8):1197-202. doi: 10.1212/wnl.58.8.1197.

  PMID: 11971086 BACKGROUND

• Padovani A, Pastorino L, Borroni B, Colciaghi F, Rozzini L, Monastero R, Perez J, Pettenati C, Mussi M, Parrinello G, Cottini E, Lenzi GL, Trabucchi M, Cattabeni F, Di Luca M. Amyloid precursor protein in platelets: a peripheral marker for the diagnosis of sporadic AD. Neurology. 2001 Dec 26;57(12):2243-8. doi: 10.1212/wnl.57.12.2243.

  PMID: 11756604 BACKGROUND

• Borroni B, Colciaghi F, Pastorino L, Pettenati C, Cottini E, Rozzini L, Monastero R, Lenzi GL, Cattabeni F, Di Luca M, Padovani A. Amyloid precursor protein in platelets of patients with Alzheimer disease: effect of acetylcholinesterase inhibitor treatment. Arch Neurol. 2001 Mar;58(3):442-6. doi: 10.1001/archneur.58.3.442.

  PMID: 11255448 BACKGROUND

MeSH Terms

Conditions

Alzheimer Disease; Memory Disorders

Interventions

Donepezil

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Indans; Indenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Polycyclic Compounds

Study Officials

• Harry E Gwirtsman, M.D.

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2006
• First Posted: December 7, 2006
• Study Start: December 1, 2006
• Primary Completion: August 24, 2012
• Study Completion: August 24, 2012
• Last Updated: February 5, 2018

Record last verified: 2018-02

Locations

US (1)