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To investigate whether [18F]NAV4694 positron emission tomography (PET) scan findings have the ability to distinguish subjects with mild cognitive impairment (MCI) who progress to Alzheimer's disease (AD) from those who do not.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| [18F]NAV4694 | Experimental | Intravenous [18F]NAV4694 (8.1 mCi) administered once every 18 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| [18F]NAV4694 | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Mild Cognitive Impairment Progression to Alzheimer's Disease | Incidence of Mild Cognitive Impairment Progression to Alzheimer's Disease | 3 Years |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of [18F]NAV4694 PET Positive Scans at 18 Months Compared to Baseline | Incidence of [18F]NAV4694 PET Positive scans at 18 months compared to baseline | 18 months |
| Change in Neuro-cognitive Test Battery Scores at 6 Months Compared to Baseline |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Cornelia Reininger, MD, PhD | Navidea Biopharmaceuticals Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Banner Sun Health Research Institute | Sun City | Arizona | 85351 | United States | ||
| Galiz Research |
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| ID | Title | Description |
|---|---|---|
| FG000 | [18F]NAV4694 | Intravenous [18F]NAV4694 (8.1 mCi) administered once every 18 months [18F]NAV4694 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 13, 2014 |
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Change in Neuro-cognitive Test Battery Scores at 6 months compared to baseline |
| 6 months |
| Change in Neuro-cognitive Test Battery Scores at 12 Months Compared to Baseline | Change in Neuro-cognitive Test Battery Scores at 12 months compared to baseline | 12 months |
| Change in Neuro-cognitive Test Battery Scores at 18 Months Compared to Baseline | Change in Neuro-cognitive Test Battery Scores at 18 months compared to baseline | 18 months |
| Change in Neuro-cognitive Test Battery Scores at 24 Months Compared to Baseline | Change in Neuro-cognitive Test Battery Scores at 24 months compared to baseline | 24 months |
| Change in Neuro-cognitive Test Battery Scores at 30 Months Compared to Baseline | Change in Neuro-cognitive Test Battery Scores at 30 months compared to baseline | 30 months |
| Change in Neuro-cognitive Test Battery Scores at 36 Months Compared to Baseline | Change in Neuro-cognitive Test Battery Scores at 36 months compared to baseline | 36 months |
| Change in SUVR Scores at 18 Months Compared to Baseline | Change in SUVR scores at 18 months compared to baseline | 36 months |
| Incidence of Adverse Events Post Baseline | Incidence of Adverse Events post baseline | 3 Years |
| Hialeah |
| Florida |
| 33016 |
| United States |
| Mt. Sinai Wien Center for Alzheimer's Disease | Miami Beach | Florida | 33140 | United States |
| Compass Research | Orlando | Florida | 32806 | United States |
| Rush University Medical Center | Chicago | Illinois | 60612 | United States |
| SIU School of Medicine | Springfield | Illinois | 62702 | United States |
| McLean Hospital | Belmont | Massachusetts | 02478 | United States |
| Qunicy Medical Center, Alzheimer's Disease Center | Quincy | Massachusetts | 02169 | United States |
| Neurological Associates of Albany | Albany | New York | 12208 | United States |
| Albert Einstein College of Medicine | The Bronx | New York | 10461 | United States |
| Wake Forest School of Medicine | Winston-Salem | North Carolina | 21157 | United States |
| COMPLETED |
|
| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | [18F]NAV4694 | Intravenous [18F]NAV4694 (8.1 mCi) administered once every 18 months [18F]NAV4694 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Full Range | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants | No |
| |||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Incidence of Mild Cognitive Impairment Progression to Alzheimer's Disease | Incidence of Mild Cognitive Impairment Progression to Alzheimer's Disease | Trial terminated prior to collection of sufficient information to evaluate the outcome measure. Data not collected. | Posted | 3 Years |
|
| |||||||||||||||||||
| Secondary | Incidence of [18F]NAV4694 PET Positive Scans at 18 Months Compared to Baseline | Incidence of [18F]NAV4694 PET Positive scans at 18 months compared to baseline | Trial terminated prior to collection of sufficient information to evaluate the outcome measure. Data not collected. | Posted | 18 months |
|
| |||||||||||||||||||
| Secondary | Change in Neuro-cognitive Test Battery Scores at 6 Months Compared to Baseline | Change in Neuro-cognitive Test Battery Scores at 6 months compared to baseline | Trial terminated prior to collection of sufficient information to evaluate the outcome measure. Data not collected. | Posted | 6 months |
|
| |||||||||||||||||||
| Secondary | Change in Neuro-cognitive Test Battery Scores at 12 Months Compared to Baseline | Change in Neuro-cognitive Test Battery Scores at 12 months compared to baseline | Trial terminated prior to collection of sufficient information to evaluate the outcome measure. Data not collected. | Posted | 12 months |
|
| |||||||||||||||||||
| Secondary | Change in Neuro-cognitive Test Battery Scores at 18 Months Compared to Baseline | Change in Neuro-cognitive Test Battery Scores at 18 months compared to baseline | Trial terminated prior to collection of sufficient information to evaluate the outcome measure. Data not collected. | Posted | 18 months |
|
| |||||||||||||||||||
| Secondary | Change in Neuro-cognitive Test Battery Scores at 24 Months Compared to Baseline | Change in Neuro-cognitive Test Battery Scores at 24 months compared to baseline | Trial terminated prior to collection of sufficient information to evaluate the outcome measure. Data not collected. | Posted | 24 months |
|
| |||||||||||||||||||
| Secondary | Change in Neuro-cognitive Test Battery Scores at 30 Months Compared to Baseline | Change in Neuro-cognitive Test Battery Scores at 30 months compared to baseline | Trial terminated prior to collection of sufficient information to evaluate the outcome measure. Data not collected. | Posted | 30 months |
|
| |||||||||||||||||||
| Secondary | Change in Neuro-cognitive Test Battery Scores at 36 Months Compared to Baseline | Change in Neuro-cognitive Test Battery Scores at 36 months compared to baseline | Trial terminated prior to collection of sufficient information to evaluate the outcome measure. Data not collected. | Posted | 36 months |
|
| |||||||||||||||||||
| Secondary | Change in SUVR Scores at 18 Months Compared to Baseline | Change in SUVR scores at 18 months compared to baseline | Trial terminated prior to collection of sufficient information to evaluate the outcome measure. Data not collected. | Posted | 36 months |
|
| |||||||||||||||||||
| Secondary | Incidence of Adverse Events Post Baseline | Incidence of Adverse Events post baseline | All participants | Posted | Number | Post-baseline adverse events | 3 Years |
|
|
|
Up to 36 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | [18F]NAV4694 | Intravenous [18F]NAV4694 (8.1 mCi) administered once every 18 months [18F]NAV4694 | 0 | 76 | 14 | 76 | 16 | 76 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac failure congestive | Cardiac disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Haemorrhage intracranial | Nervous system disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Hip fracture | Injury, poisoning and procedural complications | MedDRA 25.1 | Non-systematic Assessment |
| |
| Post Laminectomy Syndrome | Injury, poisoning and procedural complications | MedDRA 25.1 | Non-systematic Assessment |
| |
| Meningitis bacterial | Infections and infestations | MedDRA 25.1 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Thrombosis | Vascular disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Inguinal hernia | Gastrointestinal disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Cervical vertebral fracture | Musculoskeletal and connective tissue disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Lung carcinoma cell type unspecified stage I | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25.1 | Non-systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 25.1 | Non-systematic Assessment |
| |
| Colon cancer stage I | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25.1 | Non-systematic Assessment |
| |
| Myelopathy | Nervous system disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Knee arthroplasty | Surgical and medical procedures | MedDRA 25.1 | Non-systematic Assessment |
| |
| Squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25.1 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Gastroesophageal reflux disease | Gastrointestinal disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Dry eye | Eye disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Sleep disorder | Psychiatric disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Systolic hypertension | Vascular disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Medication error | Injury, poisoning and procedural complications | MedDRA 25.1 | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Cystitis | Infections and infestations | MedDRA 25.1 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Glaucoma | Eye disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 25.1 | Non-systematic Assessment |
| |
| Blood pressure increased | Investigations | MedDRA 25.1 | Non-systematic Assessment |
| |
| Bradycardia | Cardiac disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25.1 | Non-systematic Assessment |
| |
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25.1 | Non-systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 25.1 | Non-systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Navidea Biopharmaceuticals | 6149737555 | mblue@navidea.com |
| Dec 12, 2023 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D060825 | Cognitive Dysfunction |
| ID | Term |
|---|---|
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
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| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Denominators |
|---|
| Categories |
|---|
|