Our CSF biorepository consists of CSF, CSF cell pellet, PAXGene RNA, serum, plasma, and blood cell pellet collections from diseased and TruNormal® donors, with associated detailed clinical data corresponding to each donor visit. Collections of diseased and TruNormal® CSF comprise samples from various age groups and visit formats. New donors, repeat visits for existing donors as well as additional disease types are regularly added. All CSF is collected in the United States under IRB approved protocols. PrecisionMed, Inc. performs custom CSF collections and custom CSF processing.


Normal CSF Donors > 60 years old

The ACE (Aging Cognition Evaluation) Registry | Protocol 7009

The Ace Registry is a longitudinal biological sample bank associated with linked serial cognition data.

Memory deficit is a natural and persistent phenomenon of the aging process. A better understanding of the underlying biology of memory and memory disorder is essential for the development of accurate diagnostic biomarkers and more effective treatments.

A significant problem in the evaluation of cognition deficit in initially normal and more importantly, cognitively impaired donors, is failure to establish a reliable baseline score. Ratings in clinical research are often based on relatively few repeated measurements taken over a short period of time and often by different raters. The ACE Registry establishes robust baseline cognition scores using the same validated instrument every 6 months. In addition, by introducing reliable and validated computerized cognitive assessments, The ACE Registry also seeks to remedy some of the other cognition evaluation shortcomings. Declines in cognition are quantified with reference to a stable baseline.

To qualify for the study, subjects must exhibit normal memory function within the normal range on the word recognition task. Biological samples are banked by PrecisionMed and clinical data are stored at PrecisionMed. Coded serial blood and CSF samples with linked serial clinical and cognition data are marketed to the pharmaceutical and biotechnology industries. Participating organizations receive biological samples linked to clinical data with the results of cognition testing. Subject identifiers are stored in a separate database and are not supplied to customers .

Elderly Control Protocol 7800

Protocol 7800 is a collection of CSF and blood products from donors mostly aged >60 years. Each donor has donated samples on 2 occasions 4-12 weeks apart.


Normal CSF Donors < 60 years old

Normal Controls from Schizophrenia Collection Protocol 1022

Protocol 1022 is a collection of CSF and blood products from donors aged <60 years. These normal subjects were collected as TruNormal® controls for a collection of CSF and blood in donors diagnosed with Schizophrenia. Each donor has donated samples on 2 occasions 4-8 weeks apart.


Normal CSF Donors < 35 years old

Young Controls Protocol 7900

Protocol 7900 is a collection of CSF and blood products from donors aged <35 years. Each donor has donated samples including CSF and blood on 5 occasions over 24 hours.

Young Controls Protocol 8500

Protocol 8500 is a collection of CSF and blood products from non-smoking donors aged <35 years. Each donor has donated samples including CSF on 3 occasions over 40 hours, Blood draws were more frequent. This collection is completed and has samples available for purchase. Thirty normal non smoking subjects were enrolled into this protocol.


Normal CSF Donors > 18 years old

Mixed Age Controls Protocol 7005

Protocol 7005 is a collection of CSF and blood products from donors aged > 18 years. Each donor donates samples including CSF and blood on 3 occasions 4-6 weeks apart. This collection is ongoing and has samples available for purchase.


Diseased CSF collections

Our diseased CSF biorepository comprises the following diagnoses: Alzheimer’s Disease (AD), Mild Cognitive Impairment (MCI), Parkinson’s Disease (PD), Schizophrenia, Multiple Sclerosis (MS), Diabetic Neuropathy, Multiple System Atrophy, Major Depressive Disorder.


Alzheimer’s Disease

Alzheimer’s Disease (AD) and Mild Cognitive Impairment (MCI)

Protocol 8009

The SAMPLE Registry (Serial Alzheimer’s and MCI Prospective Longitudinal Evaluation) is an ongoing collection of correlated data and biological samples (including CSF) for the investigation of biomarkers of cognitive decline. The SAMPLE Registry is enrolling subjects, with either MCI or AD, aged 50 years and older. All subjects are recruited, evaluated, cognitively studied, and sampled from 12-15 experienced investigative sites, all US based.

Enrollment is ongoing. Six monthly samples with matched clinical data are available on a longitudinal basis. Custom requests for additional sample types, as well as more complex clinical, laboratory and/or radiographic evaluations within selected subpopulations have been added intermediately aged 50 years and older. Enrollment began in August, 2007.

Key aspects of subjects’ cognition including memory and attention are evaluated every six months with simultaneous biological sampling of CSF and blood for a period of 5 or more years.

Six monthly samples with matched clinical data are available on a longitudinal basis. The longitudinal clinical data collected in the AD and MCI subjects over the length of this study to date indicates that the MMSE scores tend to decrease and the ADAS-Cog scores tend to increase over time in both sub-groups (See slide presentation).


Parkinson’s Disease

Parkinson’s Disease Protocol 1009

Subjects must have been diagnosed with Parkinson’s disease for at least 1 year and must be on and have responded to a stable dose of dopamine therapy for at least 6 months. Onset of Parkinson’s disease must have been at age 60 or older. Subjects with neurological disease (other than Parkinson’s) are excluded.


Multiple Sclerosis

Multiple Sclerosis (MS) and Clinically Isolated

Syndrome (CIS) Protocol 5400

The Multiple Sclerosis Registry is a collection of correlated data and biological samples (including CSF) from donors diagnosed with Multiple Sclerosis or Clinically Isolated Syndrome. The MS Registry is enrolling subjects with Definite Multiple Sclerosis, Relapsing Remitting, Chronic Progressive or Secondary Progressive or Clinically Isolated Syndrome.

Six monthly samples with matched clinical data are available on a longitudinal basis. Custom requests for additional sample types, as well as more complex clinical, laboratory and/or radiographic evaluations within selected subpopulations are possible.


Schizophrenia

Schizophrenia Protocol 1022

Most donors have 2 CSF draws 4-8 weeks apart. We have matched TruNormal® CSF available for most subjects.

Donors have detailed demographic information, including medications, family history and rating scales such as the PANSS as well as the M.I.N.I or S.C.I.D. and cognition/memory testing.

Subjects met the DSM-IV diagnostic criteria for schizophrenia and schizoaffective disorder as defined in the DSM-IV (295.10, 295.20, 295.30, 295.60, 295.90, 295.70). Diagnosis is confirmed by a psychiatrist. Subjects with evidence or current history of substance abuse were excluded.


Diabetic Peripheral Neuropathy

Diabetic Peripheral Neuropathy  Protocol 3700

Protocol 3700 is a collection of CSF and blood products in type 2 diabetics with painless or painful diabetic peripheral neuropathy.  Some donors have multiple visits.


Major Depressive Disorder

Major Depressive Disorder Protocol 2109

Protocol 2109 this is a collection of CSF and blood products from donors with major depresive disorder. Donors evaluations include M.I.N.I.plus MMSE, HAM-D. This is a single visit protocol.


Multiple System Atrophy (MSA)

Multiple System Atrophy (MSA) Protocol 7400

This is a collection of CSF and blood products from donors with probable MSA.


Custom CSF Collections and Processing

PrecisionMed, Inc. performs custom CSF Collections and Processing. The ongoing IRB approved 7005 (aged 20-80) protocol allows us to rapidly perform custom CSF collection and processing in normal donors. PrecisionMed, Inc. also designs and conducts custom CSF collections in diseased populations.