UMIN-CTR Clinical Trial

Public title

Study on diagnosis of Alzheimer disease by amyloid imaging: A multi-center trial

Acronym

A PET study of amyloid imaging in Alzheimer disease

Scientific Title

Study on diagnosis of Alzheimer disease by amyloid imaging: A multi-center trial

Scientific Title:Acronym

A PET study of amyloid imaging in Alzheimer disease

Region

Japan

Condition

Healthy normal volunteers, Mild cognitive impairment (MCI), Alzheimer disease (AD)

Classification by specialty

Geriatrics

Radiology

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

Alzheimer's disease (AD) is the common cause of dementia in the elderly. Currently, clinical diagnosis of AD is based on clinical criteria that require the presence of memory impairment and at least one of several other cognitive dysfunctions. Although these criteria have been well accepted, detection of AD patients in early, or at least mild, stage of the disease is still problematic. Previous neuropathological studies have suggested that substantial deposition of diffuse plaques is considered to be the initial pathological change in AD that precedes cognitive deterioration. Thus, molecular positron emission tomography (PET) imaging that can detect diffuse plaques in vivo may be ideal for pre-symptomatic detection of AD patients. The purpose of this multi-center trial is to compare the PET imaging using [11C]BF-227 and [18F]FDG, magnetic resonance imaging (MRI), and psychological cognitive tests among healthy volunteers, mild cognitive impairment, and AD patients.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Developmental phase

Phase I,II

Primary outcomes

The molecular PET imaging using [11C]BF-227. The [11C]BF-227-PET is evaluated by cortical SUV ratios to cerebellum as a reference among healthy volunteers, mild cognitive impairment, and Alzheimer patients.

Key secondary outcomes

The comparison of FDG-PET, MRI, psychological cognitive tests, and [11C]BF-227-PET among healthy volunteers, mild cognitive impairment, and Alzheimer patients. The [11C]BF-227-PET is evaluated by cortical SUV ratios to cerebellum as a reference

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

Purpose of intervention

Type of intervention

Interventions/Control_1

Interventions/Control_2

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

35

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

1)Criteria for Normal volunteers:
Normal Volunteers are examined by FDG-PET, [11C]BF-227-PET, MRI and psychological tests. Male and female volunteers aged more than 35 years old are recruited for this study. They should understand the purpose and rationale of this study.

2)Criteria for Alzheimer disease:
Alzheimer patients diagnosed as a probable AD according to NINCDS-ADRDA are enrolled. MMSE (Mini-mental state examination) is over 18, and apparent cognitive dysfunction is present in the patients. Informed consents are obtained from patients family and possibly from patients themselves.

3)Criteria for Mild Cognitive Impairment
1.Amnestic MCI.
2.No apparent neurological and psychiatric disorders.
3.There are no neurological symptoms.
4.There are no psychiatric symptoms.
5.The patients do not show dementia.

Key exclusion criteria

1)The past and present history of alcoholism.
2)The past and present history of epilepsy
3)Education period is less than 6 years.
4)There are no persons who can give any information on patients symptoms.
5)Diabetic patients treated with insulin
6)Patients treated with antidepressants, antipsychotics, and long-term sedative-hypnotics.
7)Severe complication including malignancy, heart failure, hepatic dysfunction, renal dysfunction, endocrine disorders, etc.
8)Other patients and volunteers that investigators and medical doctors need to exclude.

Target sample size

80

Name of lead principal investigator

1st name
Middle name
Last name	Professor Kazuhiko Yanai

Organization

Tohoku University Graduate School of Medicine

Division name

Department of Pharmacology

Zip code

Address

Seiryo-machi 2-1, Aoba-Ku, Sendai 980-8575, Japan

TEL

022-717-8055

Email

Name of contact person

1st name
Middle name
Last name	Dr. Nobuyuki Okamura

Organization

Tohoku University Graduate School of Medicine

Division name

Department of Pharmacology

Zip code

Address

Seiryo-machi 2-1, Aoba-Ku, Sendai 980-8575, Japan

TEL

022-717-8058

Homepage URL

http://www.pharmacology.med.tohoku.ac.jp/

Email

yanai@med.tohoku.ac.jp

Institute

Study Group on diagnosis of Alzheimer disease by amyloid imaging using [11C]BF-227

Institute

Department

Personal name

Organization

A Grant-in Aid for Research on nano-medicine from the Ministry of Health and Welfare, Japan (2006-2008)

Organization

Division

Category of Funding Organization

Nationality of Funding Organization

Japan

Co-sponsor

1)Department of Geriatrics and Gerontology, Tohoku University School of medicine
2)Cyclotron and Radioisotope Center, Tohoku University

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

東北大学大学院医学系研究科
東京都健康長寿医療センター研究所
国立長寿医療センター

Date of disclosure of the study information

2007

Year

01

Month

10

Day

URL releasing protocol

http://www.pharmacology.med.tohoku.ac.jp/

Publication of results

Partially published

URL related to results and publications

Number of participants that the trial has enrolled

Results

Initial PET studies using [11C]BF-227 have been started at Tohoku University and Tokyo Metropolitan Institute of Gerontology. The accumulation patterns of [11C]BF-227 in Alzheimer patients were different from those of normal volunteers. Increased brain areas were consistent with those rich with amyloid plaques. The half of MCI patients showed increased accumulation of [11C]BF227. We also compared PET amyloid imaging to FDG-PET, and the preliminary results suggested the superiority of amyloid imaging.

Results date posted

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Participant flow

Adverse events

Outcome measures

Plan to share IPD

IPD sharing Plan description

Recruitment status

Completed

Date of protocol fixation

2006

Year

10

Month

01

Day

Date of IRB

Anticipated trial start date

2006

Year

10

Month

01

Day

Last follow-up date

2012

Year

03

Month

01

Day

Date of closure to data entry

2012

Year

03

Month

01

Day

Date trial data considered complete

2012

Year

03

Month

01

Day

Date analysis concluded

2012

Year

12

Month

01

Day

Other related information

The repeated measurement of [11C]BF227 would be possible during the study periods. Other PET facilities interested in amyloid imaging would be able to participate in this study.

Registered date

2006

Year

12

Month

25

Day

Last modified on

2017

Year

07

Month

03

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000676