## Protocol Section
### Identification Module
**NCT ID:** NCT06179979

**Brief Title:** PET Study With 11 C-PIB to Evaluate Amyloid Protein Deposits in Mild Cognitive Disorder, Alzheimer's Disease and Early Frontotemporal Degeneration.

**Official Title:** PET Study With 11 C-PIB to Evaluate Amyloid Protein Deposits in Mild Cognitive Disorder, Alzheimer's Disease and Early Frontotemporal Degeneration.

#### Organization Study ID Info
**ID:** PET-PIB-1
#### Organization
**Class:** OTHER
**Full Name:** IRCCS San Raffaele
### Status Module
#### Completion Date
**Date:** 2008-07-15

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2023-12-22

**Type:** ACTUAL

**Last Update Submit Date:** 2023-12-12

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2008-07-15

**Type:** ACTUAL

#### Start Date
**Date:** 2008-05-17

**Type:** ACTUAL

**Status Verified Date:** 2023-12

#### Study First Post Date
**Date:** 2023-12-22
**Type:** ACTUAL
**Study First Submit Date:** 2023-12-12
**Study First Submit QC Date:** 2023-12-12
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** IRCCS San Raffaele

#### Responsible Party

**Investigator Affiliation:** IRCCS San Raffaele

**Investigator Full Name:** Chiti Arturo

**Investigator Title:** Professor in Diagnostic Imaging and Radiotherapy Faculty of Medicine and Surgery, Vita-Salute San Raffaele University Director, Department of Nuclear Medicine, IRCCS Ospedale San Raffaele

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

### Description Module

**Brief Summary:** Preclinical and clinical data have demonstrated the ability of the 11C-PIB tracer to selectively bind accumulations of amyloid protein, a neuropathological marker characteristic of the neurodegenerative pathologies covered by this study.

The validation in larger groups of patients, and the comparison between the different clinical syndromes included in the spectrum, will allow the diagnostic and prognostic potential of the tracer to be evaluated, with important consequences for the clinical management of patients.

In particular, the tracer could play a central role in the clinical management of patients with neurodegenerative diseases and cognitive impairment.

Numerous pharmacological trials are currently underway, worldwide, for the validation of anti-amyloid drugs. In the future we could think about early monitoring with imaging of the effectiveness of the treatment.

T he FDG PET technique can be of great help in obtaining relationships between radiation damage to the brain and possibly neurological and neuropsychological deficits associates.

### Conditions Module

**Conditions:**

- Alzheimer Disease

### Design Module

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 60

**Type:** ACTUAL

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

### Interventions

#### Intervention 1

**Description:** Subjects considered suitable will undergo a clinical and neuropsychological evaluation and a PET/CT study with intravenous administration of 11C-PIB.

**Name:** PET/CT with 11C-PiB

**Type:** DIAGNOSTIC_TEST

### Outcomes Module

#### Primary Outcomes

**Description:** Comparative evaluation of the accumulation of amyloid protein in the various neurodegenerative conditions included with attention to the specificity of the tracer as an element of differential diagnosis.

**Measure:** PET/CT with 11C-PiB to characterize amyloid protein deposits in patients with neurodegenerative diseases.

**Time Frame:** 2 years

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Alzheimer's diagnosis according to the diagnostic criteria in use.

Exclusion Criteria:

* current or previous treatments with neuroactive drugs;
* pregnancy or breastfeeding.

**Maximum Age:** 80 Years

**Minimum Age:** 40 Years

**Sampling Method:** PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

**Study Population:** Adult patients with neurodegenerative diseases will be included: with mild cognitive disorder, Alzheimer's dementia and early temporal frontal degeneration.

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000003704

- Term: Dementia

- ID: D000001927

- Term: Brain Diseases

- ID: D000002493

- Term: Central Nervous System Diseases

- ID: D000009422

- Term: Nervous System Diseases

- ID: D000024801

- Term: Tauopathies

- ID: D000019636

- Term: Neurodegenerative Diseases

- ID: D000019965

- Term: Neurocognitive Disorders

- ID: D000001523

- Term: Mental Disorders

### Condition Browse Module - Browse Branches

- Abbrev: BC10

- Name: Nervous System Diseases

- Abbrev: BXM

- Name: Behaviors and Mental Disorders

- Abbrev: All

- Name: All Conditions

- Abbrev: BC18

- Name: Nutritional and Metabolic Diseases

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M3885

- Name: Alzheimer Disease

- Relevance: HIGH

- As Found: Alzheimer's Disease

- ID: M4021

- Name: Amyloidosis

- Relevance: LOW

- As Found: Unknown

- ID: M6301

- Name: Cognition Disorders

- Relevance: HIGH

- As Found: Cognitive Disorders

- ID: M29705

- Name: Cognitive Dysfunction

- Relevance: HIGH

- As Found: Cognitive Disorders

- ID: M6904

- Name: Dementia

- Relevance: LOW

- As Found: Unknown

- ID: M5204

- Name: Brain Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M5742

- Name: Central Nervous System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M23002

- Name: Tauopathies

- Relevance: LOW

- As Found: Unknown

- ID: M21558

- Name: Neurodegenerative Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M21836

- Name: Neurocognitive Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M4815

- Name: Mental Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M14473

- Name: Psychotic Disorders

- Relevance: LOW

- As Found: Unknown

- ID: T2192

- Name: Familial Alzheimer Disease

- Relevance: HIGH

- As Found: Alzheimer's Disease

### Condition Browse Module - Meshes

- ID: D000000544

- Term: Alzheimer Disease

- ID: D000060825

- Term: Cognitive Dysfunction

- ID: D000003072

- Term: Cognition Disorders

### Misc Info Module

- Version Holder: 2024-05-24
