Detection of Disease-Related Changes in Pre-Symptomatic Alzheimer's Disease

NCT01841905 | Unknown DMC

• 1 other identifier: 900,421-477
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators are conducting a study to try to improve our ability to identify older adults who are at high-risk for progression to Alzheimer's disease, several years before they have symptoms that might reduce their quality of life. The investigators believe they can increase the sensitivity of tests of memory and problem solving, by using a very small dose of a medication (scopolamine) that reduces the activity of the principal chemical system in the brain that is changing in the earliest stages of Alzheimer's disease. By pairing this "micro-dose" drug challenge (that is administered with a tiny needle placed just under the surface of the skin on the forearm), with our tests of memory and thinking, it is believed that the investigators can create a "stress test" that is very similar in concept to the use of the exercise treadmill to make the results of a heart EKG more sensitive to detect early disease, as a cardiac stress test for heart disease. The investigators want to create a similar stress test for Alzheimer's disease (AD).

Conditions

Alzheimer's Disease

Keywords

Alzheimer's Disease; Family History; Memory Concerns

Outcome Measures

Primary Outcomes (1)

• Groton Maze Learning Test

  Total number of correct moves over 5 trials on the Groton Maze Learning Test at 3 hours

  18 Months

Secondary Outcomes (12)

• Groton Maze Learning Test

  18 Months

• CogState One-Back Learning (OBK) Task

  18 Months

• 12-Item International Shopping List Test - Immediate and Delayed Recall (CogState)

  18 Months

• Rentz Face-Name Association Test

  18 Months

• Stark Pattern Separation Test

  18 Months

Study Arms (1)

Observational Study

Pre-Symptomatic Alzheimers' Disease

Other: Observational Study

Interventions

Observational Study OTHER

Observational Study

Observational Study

Eligibility Criteria

• Age: 55 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Individuals between the ages of 55 and 80 years old, and who have two risk factors for AD (subjective memory complaints as ascertained on a standardized questionnaire and a positive family history for the disease).

You may qualify if:

• Individuals between the ages of 55 and 80 years old (inclusive).
• MMSE total score \> 27
• Two risk factors for AD:
• Subjective memory complaints.
• A positive (suspected) first-degree family history for the disease.
• Permitted medications stable for at least 1 month prior to screening.
• Subjects may take stable doses of antidepressants lacking significant anticholinergic side effects (do not have a history of major depression within the past year).
• Estrogen replacement therapy.
• Adequate visual and auditory acuity to allow neuropsychological testing.
• Good general health or without any clinically significant abnormalities .
• Vitamin supplements (including Vitamin E) will be acceptable.
• Subjects must be willing and able to provide written informed consent.

You may not qualify if:

• History of major traumatic brain injury, other known neurologic disease or insult
• Mini Mental State Examination (MMSE)total score \< 27
• Regular (daily) use of narcotics or antipsychotic medications
• Poorly-controlled major depression or another Axis I psychiatric disorder as described in DSM-IV within the past year.
• Psychotic features, agitation or behavioral problems, within the last 3 months.
• History of alcohol or substance abuse or dependence within the past 2 years (DSM IV criteria).
• History of schizophrenia (DSM IV criteria).
• Any significant systemic illness or unstable medical condition which could lead to difficulty complying with the protocol including:
• History of systemic cancer within the past 5 years (non-metastatic skin cancers are acceptable).
• History of myocardial infarction in the past year or unstable or severe cardiovascular disease including angina or Congestive Heart Failure (CHF) with symptoms at rest.
• Clinically significant obstructive pulmonary disease or asthma.
• Clinically significant and unstable gastrointestinal disorder within two years.
• Insulin-requiring diabetes or uncontrolled diabetes mellitus.
• Uncontrolled hypertension (systolic BP \> 170 or diastolic BP \> 100).
• History of clinically significant liver disease, coagulopathy, or vitamin K deficiency within the past 2 years.

Sponsors & Collaborators

• Rhode Island Hospital: lead
• Pfizer: collaborator
• Heidelberg Engineering, Inc.: collaborator
• Neurotrack: collaborator
• Optovue: collaborator
• Avid Pharmaceuticals: collaborator

Study Sites (1)

Lifespan

Providence, Rhode Island, 02903, United States

Location

MeSH Terms

Conditions

Alzheimer Disease

Interventions

Observation

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Study Officials

• Peter J. Snyder, Ph.D.

  Sr. Vice President & Chief Research Officer, Lifespan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2013
• First Posted: April 29, 2013
• Study Start: July 1, 2013
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: January 20, 2016

Record last verified: 2016-01

Locations

US (1)