Detection of Individuals with Preclinical, Prodromal and Mild Alzheimer's Disease for Therapeutic Trials.

Detection of Individuals with Preclinical, Prodromal and Mild Alzheimer's Disease optimizing the use of cognitive and blood biomarker findings to increase the rate of amyloid scan positive subjects using Amyloid and Fluorodeoxyglucose Positron Emission Tomography (FDG PET) imaging for Therapeutic trials.

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12615000042549

Acronym

NIL

Enrollment

300

Registered

2015-01-21

Start date

2014-12-17

Completion date

2018-12-01

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This study aims to use recent advances in PET scanning techniques, in particular Amyloid scanning to assist in the detection of Preclinical, Prodromal and Mild Alzheimer's disease.

Interventions

Cognitive assessment will be performed at visits one and four lasting approximately one hour. Blood biomarker sampling will occur at visit 4. The Amyloid PET scan will be done at visit two and involves intravenous injection of 200 +/-10%MBq of (18F)Nav4694. A 20-minute scan will be acquired starting at 50 minutes post injection. Where MRI Brain scan results with a 3D sequence from within the past six months are not available, an MRI will be done at visit 2 or visit 3. An FDG PET scan will be

Study design

Allocation

Non-randomised trial

Intervention model

Single group

Primary purpose

Diagnosis

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

50 Years to 85 Years

Healthy volunteers

Inclusion criteria

Mild cognitive impairment or mild Alzheimer's Disease. > 6years of education. Adequate English and visual and auditory acuity for psychometric testing. Able to undergo MRI imaging. MMSE 20 and above. An interest in research participation.

Exclusion criteria

Other neurodegenerative disorders, severe mental illnesses. History of cancer within the last 5 years (excluding skin or insitu prostate cancer). Drug and alcohol abuse. MRI contraindications.

Outcome results