Visit Numbers in CoRRIE Reference Information

The purpose of this document is to reflect how visit numbers are used in CoRRIE by different studies

ALERTT

The ALERTT study is a non-treatment research study that focuses on tau tangles. The study determines how fast or slow tangles accumulate in different stages of Alzheimer’s disease and in normal brain aging. Learning how fast tangles change allows scientists to design more efficient clinical trials to speed up the pace of discovery for an effective treatment for AD.

The ALERTT study uses the visit number to represent which stage in the study the participant is in. the screening visit needs to be within 60 days of the Baseline visit.


The visits are labeled as follows:

(1) Screening :MRI, PIB PET Scan, Cognitive Testing (MMSE, CDR, ADAS-cog)

(2) Baseline: MK6240 PET Scan

(3-5) Participants can choose any three follow up visits, in order, from the following months:

  1. 6 Month Follow Up : MRI, MK6240 PET Scan, Cognitive Testing (MMSE, CDR, no ADAS)
  2. 12 Month Follow Up: MRI, MK6240 PET Scan, Cognitive Testing (MMSE, CDR, ADAS-cog)
  3. 18 Month Follow Up: MRI, MK6240 PET Scan, Cognitive Testing (MMSE, CDR, ADAS-cog if applicable)
  4. 24 Month Follow Up: MRI, MK6240 PET Scan, Cognitive Testing (MMSE, CDR, ADAS-cog)
  5. 30 Month Follow Up: MRI, MK6240 PET Scan, Cognitive Testing (MMSE, CDR, ADAS-cog)


LEAD

The LEAD study is interested in understanding white matter and how it is affected by Alzheimer’s disease. The goal of the study is to identify early white matter changes to help better understand how AD spreads in the brain.

The study consist of three visits every 24 months and the following procedures are repeated at each visit:

  1. MRI
  2. Blood Draw
  3. Optional LP

The LEAD study uses the visit number to specify whether the visit is

(1) Baseline OR;
(2-6) Follow-ups, with a minimum of 2 total visits and a maximum of 6 total visits for each participant to reach study completion goal


LIFE

The goal of the Longitudinal Impact of Fitness and Exercise (LIFE) study is to obtain information about aerobic fitness and physical activity in order to better understand how aerobic fitness and physical activity might help promote healthy brain aging and delay the onset of clinical symptoms of AD in the future.

LIFE has two visits (Baseline and Follow-Up) two years apart. Each visit takes place over 1-2 days and includes the following:

  1. Vitals collection
  2. Two blood draws (pre- and post-exercise)
  3. A treadmill exercise test
  4. MRI scan
  5. Lumbar puncture
  6. Filling out Questionnaires
  7. Receiving an accelerometer (small device that records physical activity)

The LIFE study uses

(1) to represent all activities that occurred at Baseline, and

(2) to represent all activities that occurred at the Follow-Up visit

 

PET (ADRC/WRAP PET Protocol)

The ADRC/ WRAP PET Protocol is a brain imaging research study that identifies how AD develops by imaging amyloid plaques and neurofibrillary tangles. The goal is to determine the agreement between the biomarkers and clinical diagnosis and to determine how far in advance of symptoms AD begins. The following scans are conducted at each visit:

  1. MK6240 PET
  2. PiB PET
  3. MRI (If applicable)

The PET Study uses visit numbers to represent the following:

(1) Baseline visit (Visit 1)

(2) Follow Up at approximately 24 months (Visit 2)


PREDICT

The PREDICT Study observes predictors of cognitive change from normal to early stages of MCI to dementia. The major aims of the study are to characterize the spatial burden of tau and amyloid and examine their interaction or cumulative effect on longitudinal cognitive decline.

Predict-2 is a continuation of Predict-1.

The following procedures occur at each visit:

  1. MRI (Optional at visit 2)
  2. PiB PET
  3. MK6240 PET
  4. Optional LP

The Visit Numbers are used to represent the following:

(1) Baseline visit (Predict-2 Visit 1)

(2) Follow Up/ 24 month visit (Predict-2 Visit 2)


SYNAPSE

The SYNAPSE study uses PET brain scans to visualize neuronal synapse density, amyloid plaques, and neurofibrillary tangles; and examines whether AD pathology affects the quantity of synapses, and whether loss of synapses over time is associated with cognitive decline.

The following procedures occur at each visit:

  1. MRI (If not done with ADRC or WRAP in the past year)
  2. PiB PET
  3. MK6240 PET
  4. UCB-J PET
  5. Optional FDG PET
  6. Optional LP

The Synapse study uses the visit number to specify whether or not the visit is

(1) Baseline ,OR

(2) Follow-Up


These same visit numbers are used to represent all of the procedures done at Baseline or Follow-Up, even if these procedures occur on different days.

 

WRAP

The Wisconsin Registry for Alzheimer’s Prevention (WRAP) study is a comprehensive data set that includes cognition, lifestyle, physical activity, biomarkers, genetics, and metabolism. The WRAP study consists of approximately 1,580 individuals, followed over time, to learn about biological, health and lifestyle factors that may affect the disease. WRAP has two different assessments- the entry level assessment and the subsequent assessments. Participants come in for an initial study visit, and then for a follow-up visit approximately every 2 years. WRAP does not have a maximum number of visits a participant should complete, and the observational duration is until age 85 or until the endpoint of dementia or other stopping point .The study plans to continue as long as funds permit.

 

Participation in WRAP includes:

  1. Cognitive Testing
  2. Blood Draw
  3. Medical Exam (when possible)
  4. Optional MRI
  5. Optional Lumbar Puncture
  6. Optional MK6240 PET
  7. Optional PiB PET

WRAP uses the visit numbers to represent the wave of the visit the participant is coming in for. Thus;

(1) Is used to represent the ppt’s first visit

(2) Is used to represent the ppt’s second visit

(3) Is used to represent the ppt’s third visit, and so on…


WRAP LP biomarker visits do not have waves associated with them, and the date the visit was conducted is used as the identifier instead. WRAP MRI biomarker visits have waves associated with them, and (1) would mean first visit under the WRAP imaging protocol, (2) second visit under the WRAP imaging protocol, and so on.



Document History
Version DateEffective DateChange ReasonPrimary Author
Jun 17, 2020
OriginalCalanthea Mazoyo
December 21, 2021December 21, 2021Updated study processes to accommodate covid-19 disruptionsCalanthea Mazoyo




Keywords:WRAP, ADRC, CoRRIE, Visit Numbers, Alertt, Lead, life, PET, Predict, Synapse   Doc ID:103127
Owner:Calanthea W.Group:Wisconsin Alzheimer’s Program
Created:2020-06-17 10:18 CSTUpdated:2022-03-08 08:38 CST
Sites:Wisconsin Alzheimer’s Program
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