Trial Outcomes & Findings for Beta-Amyloid Imaging With [18F]NAV4694 PET in Predicting Progression to AD in Subjects MCI (NCT NCT01812213)

NCT ID: NCT01812213

Last Updated: 2024-08-14

Results Overview

Incidence of Mild Cognitive Impairment Progression to Alzheimer's Disease

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

76 participants

Primary outcome timeframe

3 Years

Results posted on

2024-08-14

Participant Flow

Participant milestones

Participant milestones
Measure	[18F]NAV4694 Intravenous \[18F\]NAV4694 (8.1 mCi) administered once every 18 months \[18F\]NAV4694
Overall Study STARTED	76
Overall Study COMPLETED	39
Overall Study NOT COMPLETED	37

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Beta-Amyloid Imaging With [18F]NAV4694 PET in Predicting Progression to AD in Subjects MCI

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	[18F]NAV4694 n=76 Participants Intravenous \[18F\]NAV4694 (8.1 mCi) administered once every 18 months \[18F\]NAV4694
Age, Continuous	76 years n=5 Participants
Sex: Female, Male Female	25 Participants n=5 Participants
Sex: Female, Male Male	51 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	10 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	66 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants
Race (NIH/OMB) White	72 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: 3 Years

Population: Trial terminated prior to collection of sufficient information to evaluate the outcome measure. Data not collected.

Incidence of Mild Cognitive Impairment Progression to Alzheimer's Disease

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 18 months

Population: Trial terminated prior to collection of sufficient information to evaluate the outcome measure. Data not collected.

Incidence of \[18F\]NAV4694 PET Positive scans at 18 months compared to baseline

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 months

Population: Trial terminated prior to collection of sufficient information to evaluate the outcome measure. Data not collected.

Change in Neuro-cognitive Test Battery Scores at 6 months compared to baseline

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 months

Population: Trial terminated prior to collection of sufficient information to evaluate the outcome measure. Data not collected.

Change in Neuro-cognitive Test Battery Scores at 12 months compared to baseline

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 18 months

Population: Trial terminated prior to collection of sufficient information to evaluate the outcome measure. Data not collected.

Change in Neuro-cognitive Test Battery Scores at 18 months compared to baseline

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 24 months

Population: Trial terminated prior to collection of sufficient information to evaluate the outcome measure. Data not collected.

Change in Neuro-cognitive Test Battery Scores at 24 months compared to baseline

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 30 months

Population: Trial terminated prior to collection of sufficient information to evaluate the outcome measure. Data not collected.

Change in Neuro-cognitive Test Battery Scores at 30 months compared to baseline

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 36 months

Population: Trial terminated prior to collection of sufficient information to evaluate the outcome measure. Data not collected.

Change in Neuro-cognitive Test Battery Scores at 36 months compared to baseline

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 36 months

Population: Trial terminated prior to collection of sufficient information to evaluate the outcome measure. Data not collected.

Change in SUVR scores at 18 months compared to baseline

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 3 Years

Population: All participants

Incidence of Adverse Events post baseline

Outcome measures

Outcome measures
Measure	[18F]NAV4694 n=76 Participants Intravenous \[18F\]NAV4694 (8.1 mCi) administered once every 18 months \[18F\]NAV4694
Incidence of Adverse Events Post Baseline	43 Post-baseline adverse events

Adverse Events

[18F]NAV4694

Serious events: 14 serious events

Other events: 16 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	[18F]NAV4694 n=76 participants at risk Intravenous \[18F\]NAV4694 (8.1 mCi) administered once every 18 months \[18F\]NAV4694
Cardiac disorders Cardiac failure congestive	1.3% 1/76 • Number of events 2 • Up to 36 months
Nervous system disorders Haemorrhage intracranial	1.3% 1/76 • Number of events 1 • Up to 36 months
Injury, poisoning and procedural complications Hip fracture	2.6% 2/76 • Number of events 2 • Up to 36 months
Injury, poisoning and procedural complications Post Laminectomy Syndrome	1.3% 1/76 • Number of events 1 • Up to 36 months
Infections and infestations Meningitis bacterial	1.3% 1/76 • Number of events 1 • Up to 36 months
Nervous system disorders Headache	1.3% 1/76 • Number of events 1 • Up to 36 months
Vascular disorders Thrombosis	1.3% 1/76 • Number of events 1 • Up to 36 months
Gastrointestinal disorders Gastrointestinal haemorrhage	1.3% 1/76 • Number of events 1 • Up to 36 months
Gastrointestinal disorders Inguinal hernia	1.3% 1/76 • Number of events 1 • Up to 36 months
Musculoskeletal and connective tissue disorders Cervical vertebral fracture	1.3% 1/76 • Number of events 1 • Up to 36 months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung carcinoma cell type unspecified stage I	1.3% 1/76 • Number of events 1 • Up to 36 months
Infections and infestations Influenza	1.3% 1/76 • Number of events 1 • Up to 36 months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer stage I	1.3% 1/76 • Number of events 1 • Up to 36 months
Nervous system disorders Myelopathy	1.3% 1/76 • Number of events 1 • Up to 36 months
Surgical and medical procedures Knee arthroplasty	1.3% 1/76 • Number of events 1 • Up to 36 months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma	1.3% 1/76 • Number of events 1 • Up to 36 months

Other adverse events

Other adverse events
Measure	[18F]NAV4694 n=76 participants at risk Intravenous \[18F\]NAV4694 (8.1 mCi) administered once every 18 months \[18F\]NAV4694
Gastrointestinal disorders Nausea	1.3% 1/76 • Number of events 2 • Up to 36 months
Gastrointestinal disorders Diarrhoea	2.6% 2/76 • Number of events 2 • Up to 36 months
Nervous system disorders Headache	2.6% 2/76 • Number of events 2 • Up to 36 months
Gastrointestinal disorders Gastroesophageal reflux disease	1.3% 1/76 • Number of events 1 • Up to 36 months
Eye disorders Dry eye	1.3% 1/76 • Number of events 1 • Up to 36 months
Psychiatric disorders Sleep disorder	1.3% 1/76 • Number of events 1 • Up to 36 months
Vascular disorders Systolic hypertension	1.3% 1/76 • Number of events 1 • Up to 36 months
Gastrointestinal disorders Vomiting	1.3% 1/76 • Number of events 1 • Up to 36 months
Nervous system disorders Dizziness	1.3% 1/76 • Number of events 1 • Up to 36 months
Injury, poisoning and procedural complications Medication error	1.3% 1/76 • Number of events 1 • Up to 36 months
Psychiatric disorders Insomnia	1.3% 1/76 • Number of events 1 • Up to 36 months
Infections and infestations Cystitis	1.3% 1/76 • Number of events 1 • Up to 36 months
General disorders Fatigue	1.3% 1/76 • Number of events 1 • Up to 36 months
Eye disorders Glaucoma	1.3% 1/76 • Number of events 1 • Up to 36 months
Infections and infestations Urinary tract infection	1.3% 1/76 • Number of events 1 • Up to 36 months
Investigations Blood pressure increased	1.3% 1/76 • Number of events 1 • Up to 36 months
Cardiac disorders Bradycardia	1.3% 1/76 • Number of events 1 • Up to 36 months
General disorders Asthenia	1.3% 1/76 • Number of events 1 • Up to 36 months
Vascular disorders Hypertension	1.3% 1/76 • Number of events 1 • Up to 36 months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma	1.3% 1/76 • Number of events 1 • Up to 36 months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	1.3% 1/76 • Number of events 1 • Up to 36 months
Gastrointestinal disorders Abdominal pain upper	1.3% 1/76 • Number of events 1 • Up to 36 months

Additional Information

Chief Medical Officer

Navidea Biopharmaceuticals

Phone: 6149737555

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place