Genetic and Biomarker Study of Alzheimer's Disease

Study ID
STU 082010-275

Cancer Related
No

Healthy Volunteers
Yes

Study Sites

Contact
Barbara Davis
214-648-9367
barb.davis@utsouthwestern.edu

Principal Investigator
C Munro Cullum

Summary

The goal of the Consortium is to develop a longitudinal multidisciplinary study of alzheimer's disease. The study population will include individuals currently being followed at the five Consortium member sites. This longitudinal dataset will take advantage of data already collected from consenting individuals as well as newly acquired data on genetic polymorphisms, inflammatory biomarkers, olfactory test, and clinical laboratory parameters to address the current hypotheses. once enrolled, this prospective cohort will be followed annually and will be enriched with additional participants as funding becomes available.

The Consortium will attempt follow-up of all individuals recruited previously (500 aD patients and 300 cognitively normal individuals). Recruitment of new subjects will also continue in order to enrich the cohort with 125 individuals with MCi, 100 Mexican-americans with aD, 150 with MCi and 450 cognitively normal Mexican-americans. Recruitment to offset loss to follow-up (estimated attrition rate of 30%) will also continue. in addition, in october 2011 the Steering Committee agreed that a stronger focus on early stages of alzheimer's was desirable. accordingly, a shift in enrollment to reduce the number of Caucasian aDs and increase the number of Caucasian MCis and controls was approved. This shift was planned to be gradual in nature to avoid disruption of ongoing follow-up efforts. attempts would be made to enroll additional Caucasian MCis or controls only when a Caucasian aD participant attrited from the study.

Diagnosis will be based on consensus review, which is required at baseline and at follow-up visits for all subjects (aD, MCi, and Controls).

all potential participants will be selected from current clinical and research efforts ongoing at each Consortium institution. after iRB approved consent to participate has been obtained from each individual, a blood sample will be collected along with all demographic and clinical information required to answer the research questions. Blood will be collected at their scheduled yearly research visit if it occurs during the recruitment period, if not potential participants who are a part of our aDC Center may be contacted and asked to come in for an additional study visit if they are willing to participate in this study. a finger stick blood glucose will be assessed using the accu-chek Compact Plus glucometer, Lancets and test strips. The finger stick will be performed after an overnight fast at baseline and each follow-up visit

Participant Eligibility

AD
Inclusion Criteria
Diagnosis of AD status is based on NINCDS-ADRDA criteria128.

* Men and women >=50 years of age with a diagnoses of Probable AD

* Must have information regarding duration of symptoms of dementia

* MMSE score >16 (Hispanic subjects >= 11) with WORLD

* Must be willing and able to provide a blood specimen at baseline

* Participants should be residents of Texas or a surrounding state, within the catchment area for the center where they are enrolled, with the expectation that they will be able to return for follow-up visits.

* All information must be informantxbased (provided by someone other than the person being recruited) with reliability of informant based on judgment of examiner
Mild Cognitive Impairment (MCI)
Inclusion Criteria

* Men and women >=50 years of age with diagnosis of MCI (see Diagnosis of MCI below)

* Must have information regarding duration of symptoms of MCI

* Must be willing and able to provide a blood specimen at baseline

* Participants should be residents of Texas or a surrounding state, within the catchment area for the center where they are enrolled, with the expectation that they will be able to return for follow-up visits.

* All information must be informantxbased (provided by someone other than the person being recruited) with reliability of informant based on judgment of examiner

Diagnosis of MCI based on the following:

* Cognitive complaint, confirmed by informant

* Cognition judged to be impaired for age and confirmed by neuropsychological testing

* Preserved general cognitive functioning

* Instrumental activities of daily living consistent with a diagnosis of MCI in the opinion of the clinician/consensus review

* Not demented; CDR Sum of Boxes score >= 0.5 and global CDR < 1

All subtypes of MCI (Amnestic x single domain, Amnestic x multi domain, Non-Amnestic x single domain, Non-Amnestic x multi domain) will be recruited.

Note: MCI is a clinical diagnosis without reliance on specific neurocognitive tests and/or cut-scores. However, all MCI patients must undergo consensus-based diagnosis similar to AD and control participants and all available information should be reviewed to assign this clinical diagnosis. It is expected that some form of a list-learning task will be included as part of the neuropsychological examinations at each site to capture the milder forms of amnestic-related MCI.
Cognitively normal controls
Inclusion Criteria

* Men and women >=50 years of age

* CDR Global Score = 0 and CDR Sum of Box Score = 0

* Normal cognition and function based on reliable informant report

* Judged to be cognitively within normal limits based on consensus review, including neuropsychological testing

* Must be willing and able to provide a blood specimen at baseline

* Participants should be residents of Texas or a surrounding state, within the catchment area for the center where they are enrolled, with the expectation that they will be able to return for follow-up visits.

* All information must be Informantxbased (provided by someone other than the person being recruited) with reliability of informant based on judgment of examiner

Potentially allowable conditions

* History of conditions having the potential to affect cognition (e.g., heart attack, mild head injury) are allowed, providing no evidence of residual cognitive dysfunction on general medical evaluation and condition no longer active

* Active, chronic medical disease (e.g. diabetes, hypertension, thyroid) providing condition is adequately controlled and not causing cognitive compromise

* Subjects who are treated for depression but do not currently meet criteria for Major Depressive Disorder can be included.